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    Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a)D 3.2MM X 10MM (002-D-32010) b) D 3.2MM X 12MM (002-D-32012) c) D 3.2MM X 14MM (002-D-32014) d) D 3.2MM X 16MM (002-D-32016) e) D 3.2MM X 18MM (002-D-32018) f) D 3.2MM X 20MM (002-D-32020) g) D 3.2MM X 22MM (002-D-32022) h) D 3.2MM X 24MM (002-D-32024) i) D 3.2MM X 26MM (002-D-32026) j) D 3.2MM X 28MM (002-D-32028) k) D 3.2MM X 30MM (002-D-32030) l) D 3.2MM X 32MM (002-D-32032) m) D 3.2MM X 34MM (002-D-32034) n) D 3.2MM X 36MM (002-D-32036) o) D 3.2MM X 38MM (002-D-32038) p) D 3.2MM X 40MM (002-D-32040) q) D 3.2MM X 42MM (002-D-32042) r) D 3.2MM X 44MM (002-D-32044) s) D 3.2MM X 46MM (002-D-32046) t) D 3.2MM X 48MM (002-D-32048) u) D 3.2MM X 50MM (002-D-32050)

    FDA Enforcement
    Class II ·Terminated·Orthofix, Inc·June 13, 2018

    Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 3.2MM X 10MM (002-E-32010) b) D 3.2MM X 12MM (002-E-32012) c) D 3.2MM X 14MM (002-E-32014) d) D 3.2MM X 16MM (002-E-32016) e) D 3.2MM X 18MM (002-E-32018) f) D 3.2MM X 20MM (002-E-32020) g) D 3.2MM X 22MM (002-E-32022) h) D 3.2MM X 24MM (002-E-32024) i) D 3.2MM X 26MM (002-E-32026) j) D 3.2MM X 28MM (002-E-32028) k) D 3.2MM X 30MM (002-E-32030) l) D 3.2MM X 32MM (002-E-32032) m) D 3.2MM X 34MM (002-E-32034) n) D 3.2MM X 36MM (002-E-32036) o) D 3.2MM X 38MM (002-E-32038) p) D 3.2MM X 40MM (002-E-32040) q) D 3.2MM X 42MM (002-E-32042) r) D 3.2MM X 44MM (002-E-32044) s) D 3.2MM X 46MM (002-E-32046) t) D 3.2MM X 48MM (002-E-32048) u) D 3.2MM X 50MM (002-E-32050)

    FDA Enforcement
    Class II ·Terminated·Orthofix, Inc·June 13, 2018

    Poly Component Trial, MPCS, packaged in the following sizes and configurations: a) Poly Component Trial - MPCS 3x10L, REF 90-SRK-192310 b) Poly Component Trial - MPCS 3x10R, REF 90-SRK-191310 c) Poly Component Trial - MPCS 3x12L, REF 90-SRK-192312 d) Poly Component Trial - MPCS 3x12R, REF 90-SRK-191312 e) Poly Component Trial - MPCS 3x14L, REF 90-SRK-192314 f) Poly Component Trial - MPCS 3x14R, REF 90-SRK-191314 g) Poly Component Trial - MPCS 4x10L, REF 90-SRK-192410 h) Poly Component Trial - MPCS 4x10R, REF 90-SRK-191410 i) Poly Component Trial - MPCS 4x12L, REF 90-SRK-192412 j) Poly Component Trial - MPCS 4x12R, REF 90-SRK-191412 k) Poly Component Trial - MPCS 4x14L, REF 90-SRK-192414 l) Poly Component Trial - MPCS 4x14R, REF 90-SRK-191414 m) Poly Component Trial - MPCS 5x10L, REF 90-SRK-192510 n) Poly Component Trial - MPCS 5x10R, REF 90-SRK-191510 o) Poly Component Trial - MPCS 5x12L, REF 90-SRK-192512 p) Poly Component Trial - MPCS 5x12R, REF 90-SRK-191512 q) Poly Component Trial - MPCS 5x14L, REF 90-SRK-192514 r) Poly Component Trial - MPCS 5x14R, REF 90-SRK-191514 s) Poly Component Trial - MPCS 6x10L, REF 90-SRK-192610 t) Poly Component Trial - MPCS 6x10R, REF 90-SRK-191610 u) Poly Component Trial - MPCS 6x12L, REF 90-SRK-192612 v) Poly Component Trial - MPCS 6x12R, REF 90-SRK-191612 w) Poly Component Trial - MPCS 6x14L, REF 90-SRK-192614 x) Poly Component Trial - MPCS 6x14R, REF 90-SRK-191614 The Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint.

    FDA Enforcement
    Class II ·Terminated·Medtronic Sofamor Danek USA Inc·March 29, 2017

    Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID, REF 21347, d) AST-GNOR, REF 22000, e) AST-GP67, REF 22226, f) AST-P612, REF 22359, g) AST-XN01, REF 410025, h) AST-N222, REF 413083, i) AST-N223, REF 413110, j) AST-N226, REF 413143, k) AST-N248, REF 413397, l) ASR-GN67, REF 413399, m) AST-GN69, REF 413400, n) AST-GN73, REF 413404, o) AST-GN79, REF 413436, p) AST-GN82, REF 413439, q) AST-N261, REF 413753, r) AST-XN06, REF 413944, s) AST-N275, REF 414313, t) AST-GP75, REF 415670, u) AST-N300, REF 416241, v) AST-N308, REF 413913, w) AST-N314, REF 417027, x) AST-N318, REF 417952, y) AST-P643, REF 418671, z) AST-YS08, REF 420739, aa) AST-N348, REF 420856, bb) AST-ST02, REF 420915, cc) AST-ST03, REF 421040, dd) AST-N355, REF 421351, ee) AST-P654, REF 421912, ff) AST-P655, REF 421913, gg) AST-N371, REF 422024, hh) AST-N372, REF 422241, ii) AST-N379, REF 423052,

    FDA Enforcement
    Class II ·Terminated·Organon Teknika Inc·March 6, 2019

    LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Labeled as the following sizes: a. 5.5mm x 35mm; b. 5.5mm x 40mm; c. 5.5mm x 45mm; d. 5.5mm x 50mm; e. 5.5mm x 55mm; f. 6.5mm x 35mm; g. 6.5mm x 40mm; h. 6.5mm x 45mm; i. 6.5mm x 50mm; j. 6.5mm x 55mm; k. 6.5mm x 60mm; l. 7.5mm x 35mm; m. 7.5mm x 40mm; n. 7.5mm x 50mm; o. 7.5mm x 55mm; p. 7.5mm x 60mm; q. 8.5mm x 35mm; r. 8.5mm x 40mm; s. 8.5mm x 45mm; t. 8.5mm x 50mm; u.8.5mm x 55mm; v. 8.5mm x 60mm; Used in spinal fixation surgery.

    FDA Enforcement
    Class II ·Terminated·Integrity Implants Inc.·December 14, 2022

    LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Labeled as the following sizes: a. 5.5mm x 35mm; b. 5.5mm x 40mm; c. 5.5mm x 45mm; d. 5.5mm x 50mm; e. 5.5mm x 55mm; f. 6.5mm x 35mm; g. 6.5mm x 40mm; h. 6.5mm x 45mm; i. 6.5mm x 50mm; j. 6.5mm x 55mm; k. 6.5mm x 60mm; l. 7.5mm x 35mm; m. 7.5mm x 40mm; n. 7.5mm x 45mm; o. 7.5mm x 50mm; p. 7.5mm x 55mm; q. 7.5mm x 60mm; r. 8.5mm x 35mm; s. 8.5mm x 40mm; t. 8.5mm x 45mm; u. 8.5mm x 50mm; v.8.5mm x 55mm; w. 8.5mm x 60mm; Used in spinal fixation surgery.

    FDA Enforcement
    Class II ·Terminated·Integrity Implants Inc.·December 14, 2022

    Halyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿System¿for¿Adults,¿Double¿Swivel¿Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54 CM (GREEN); b. HALYARD* TRACH CARE-72 DSE ENDO 14FR; c. HALYARD* TRACH CARE-72 WET PAK* 14FR; d. HALYARD* TRACH CARE-72 WET PAK* T-PIECE SWVL/FLEX ENDO 14FR; e. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5 CM (GREEN); f. HALYARD* TRACH CARE-72 DSE TRACH 14FR; g. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 14FR; h. HALYARD* TRACH CARE-72 DSE ENDO 10FR; i. HALYARD* TURBO-CLEANING 10FR DSE 12IN/30.5CM (BLACK); j. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 10FR; k. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 12FR; l. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE); m. HALYARD* 72 DSE MDI BUILT IN ENDO 12FR; n. HALYARD* 72 DSE TRACH CARE 12FR; o. HALYARD* 14FR DSE 22.2IN/56CM (GREEN); p. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 14FR; q. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5CM (GREEN); r. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 14FR; s. HALYARD* TC-72 WET PAK* DSE MDI ENDO 14FR; t. HALYARD* TC-72 WET PAK DSE MDI ENDO 14FR; u. HALYARD* TC-72 WET PAK DSE 14FR; v. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN); w. HALYARD* TURBO-CLEANING 12FR DSE 21.3IN/54 CM (WHITE); x. HALYARD* TRACH CARE-72 DSE ENDO 12FR; y. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE); z. HALYARD* TRACH CARE-72 DSE TRACH 12FR; aa. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 12FR; ab. HALYARD* TURBO-CLEANING 16FR DSE 21.3IN/54CM (ORANGE); ac. HALYARD* TRACH CARE-72 DSE 16FR 21.3IN/54CM; ad. HALYARD* TRACH CARE-72 DSE TRACH 16FR; ae. HALYARD* TRACH CARE-72 DSE ENDO 16FR; af. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 16FR; ag. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 16FR; ah. HALYARD* TRACH CARE-72 DSE MDI ENDO 16FR; ai. HALYARD* TRACH CARE-72 DSE 16FR; aj. HALYARD* TRACH CARE-72 WET PAK* DSE ENDO 12FR; ak. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN); al. HALYARD* TURBO-CLEANING 14FR DSE Endo;

    FDA Enforcement
    Class II ·Terminated·Halyard Health, Inc·April 25, 2018

    Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits labeled as the following: a. Tray Name: PACK BASIC SET UP LH - 2035102, Tray Number: LSRBASICPACD; b. Tray Name: PACK ANGIOGRAM CFH - 2071297, Tray Number: LSRCFHANGD; c. Tray Name: PACK BASIC VIII CFH - 2073903, Tray Number: LSRCFBVIIIPKE; d. Tray Name: PACK BASIC VIII CFH -2072667, Tray Number: LSRCFBVIIIPKD; e. Tray Name: PACK BREAST GARRAMONE, Tray Number: LSRGABRSB; f. Tray Name: PACK CARDIAC CATH LH - 2073653, Tray Numbers: LSRCARDCATHF, LSRCFHCATHE; g. Tray Name: PACK CAROTID CFH - 2022261, Tray Number: LSRCFHCARC; h. Tray Name: PACK CAROTID CFH - 2070082, Tray Number: LSRCFHCARD; i. Tray Name: PACK CATH PACK CFH - 2065429, Tray Number: LSRCFHCATHD; j. Tray Name: PACK CYSTO-TUR CFH - 2066423, Tray Number: LSRCFHCYTURC; k. Tray Name: PACK D-C GYN CFH - 2023208, Tray Number: LSRCFHDCGYNC; l. Tray Name: PACK D-C LH - 2067690, Tray Number: LSRLMDCA; m. Tray Name: PACK EENT CFH - 2023005, Tray Number: LSRCFENTB; n. Tray Name: PACK EENT CFH - 2073904, Tray Number: LSRCFENTC; o. Tray Name: PACK ENDOSCOPIC LH - 2073429, Tray Numbers: LSRENDOSCOPG, LSRENDOSCOPH; p. Tray Name: PACK ENDOVENOUS LH - 2072299, Tray Number: LSRLMENDOVB; q. Tray Name: PACK GENERIC A - 2018972, Tray Number: LSRMISCA; r. Tray Name: PACK HP GYN LAPAROSCOPY LH -2067955, Tray Number: LSRHPGYND; s. Tray Name: PACK KNEE ARTHROSCOPY SMHS - 2065237, Tray Number: LSRKNEEARTHF; t. Tray Name: PACK OCCULAR DRAPE LH - 2034766, Tray Number: LSROCCULARC; u. Tray Name: PACK OPHTHALMOLOGY LH - 2034932, Tray Number: LSROPHTHALD; v. Tray Name: PACK PICC LINE LH - 2008070, Tray Number: LSRPICCLINEG; w. Tray Name: PACK SHOULDER SMHS - 2065241, Tray Number: LSRSHOULDERD; x. Tray Name: PACK SINGLE BASIN LH - 2064837, Tray Number: LSRSINGLEBA; y. Tray Name: PACK STOCK PACEMAKER CFH - 2069578, Tray Number: LSRCFHPACRE; z. Tray Name: PACK VAGINAL DELIVERY SMHS - 2068301, Tray Number: LSRVAGDELIVC; aa. Tray Name: PACK CYSTO DECATUR - 2047265, Tray Number: LSRDECYSTA; bb. Tray Name: PACK MINOR DECATUR - 2071628, Tray Number: LSRDEMINB

    FDA Enforcement
    Class II ·Terminated·American Contract Systems, Inc.·March 6, 2019

    Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: a. VERSYS 6 INCH BEADED FC 19X160MM STD BODY STD NECK (Item No. 00894301906); b. VERSYS 6 INCH BEADED FC 21X160MM STD BODY STD NECK (Item No. 00784302106); c. VERSYS 6 INCH BEADED FC 22X160MM STD BODY STD NECK (Item No. 00784302206); d. VERSYS 6 INCH BEADED FC STEM 19X160MM LM (Item No. 00784301936); e. VERSYS 6 INCH BEADED FC STEM 20X160MM LM (Item No. 00784302036); f. VERSYS 6 INCH BEADED FC STEM 21X160MM LM (Item No. 00784302136); g. VERSYS 6 INCH BEADED FC STEM 22X160MM LM (Item No. 00784302236); h. VERSYS 6 INCH BEADED FC 14X160MM STD BODY STD NECK (Item No. 00784301406); i. VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK (Item No. 00784301506); j. VERSYS 6 INCH BEADED FC 16X160MM STD BODY STD NECK (Item No. 00784301606); k. VERSYS 6 INCH BEADED FC 17X160MM STD BODY STD NECK (Item No. 00784301706); l. VERSYS 6 INCH BEADED FC 18X160MM STD BODY STD NECK (Item No. 00784301806); m. VERSYS 6 INCH BEADED FC 18X160MM STD BODY EXT NECK (Item No. 00784301826); n. VERSYS 6 INCH BEADED FC 19X160MM STD BODY EXT NECK (Item No. 00784301926); o. VERSYS 6 INCH BEADED FC 20X160MM STD BODY STD NECK (Item No. 00784302006); p. VERSYS 6 INCH BEADED FC 20X160MM STD BODY EXT NECK (Item No. 00784302026); q. VERSYS 6 INCH BEADED FC 21X160MM STD BODY EXT NECK (Item No. 00784302126); r. VERSYS 6 INCH BEADED FC 22X160MM STD BODY EXT NECK (Item No. 00784302226); s. VERSYS 6 INCH BEADED FC 17X160MM LM BODY XEXT NECK (Item No. 00784301746); t. VERSYS 6 INCH BEADED FC 17X160MM LM BODY EXT NECK (Item No. 00784301756 u. VERSYS 6 INCH BEADED FC STEM 18X160MM LM (Item No. 00784301836); v. VERSYS 6 INCH BEADED FC 18X160MM LM BODY XEXT NECK (Item No. 00784301846); w. VERSYS 6 INCH BEADED FC 18X160MM LM BODY EXT NECK (Item No. 00784301856); x. VERSYS 6 INCH BEADED FC 19X160MM LM BODY XEXT NECK (Item No. 00784301946); y. VERSYS 6 INCH BEADED FC 19X160MM LM BODY EXT NECK (Item No. 00784301956); z. VERSYS 6 INCH BEADED FC 20X160MM LM BODY XEXT NECK (Item No. 00784302046); aa. VERSYS 6 INCH BEADED FC 20X160MM LM BODY EXT NECK (Item No. 00784302056); ab. VERSYS 6 INCH BEADED FC 21X160MM LM BODY XEXT NECK (Item No. 00784302146); ac. VERSYS 6 INCH BEADED FC 21X160MM LM BODY EXT NECK (Item No. 00784302156); ad. VERSYS 6 INCH BEADED FC 22X160MM LM BODY XEXT NECK (Item No. 00784302246); ae. VERSYS 6 INCH BEADED FC 22X160MM LM BODY EXT NECK (Item No. 00784302256) Components of the system are intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia, and/or total knee in cases that require extensive resection and restoration.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 7, 2018

    LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Labeled as the following sizes: a. 5.5mm x 35mm; b. 5.5mm x 40mm; c. 5.5mm x 45mm; d. 5.5mm x 50mm; e. 6.5mm x 35mm; f. 6.5mm x 40mm; g. 6.5mm x 45mm; h. 6.5mm x 50mm; i. 6.5mm x 55mm; j. 7.5mm x 35mm; k. 7.5mm x 40mm; l. 7.5mm x 45mm; m. 7.5mm x 50mm; n. 7.5mm x 55mm; o. 8.5mm x 35mm; p. 8.5mm x 40mm; q. 8.5mm x 45mm; r. 8.5mm x 50mm; s.8.5mm x 55mm; t. 9.5mm x 35mm; u. 9.5mm x 40mm; v. 9.5mm x 45mm; w. 9.5mm x 50mm; x. 9.5mm x 55mm; Used in spinal fixation surgery.

    FDA Enforcement
    Class II ·Terminated·Integrity Implants Inc.·December 14, 2022

    4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in kits labeled as follows: a) M-FAK Mini First Aid Kit; Kit Product Code: 80-0890 b) M-FAK Mini First Aid Kit, with Bleeding Control Dressing; Kit Product Code: 80-0891 c) M-FAK Mini First Aid Kit, Advance; Kit Product Code: 80-0892 d) M-FAK Mini First Aid Kit, Basic; Kit Product Code: 80-0913 e) M-FAK Mini First Aid Kit; Kit Product Code: 80-0914 f) Trauma and First Aid Kit; Kit Product Code: 80-0947 g) Trauma and First Aid Kit; Kit Product Code: 80-0948 h) Trauma and First Aid Kit; Kit Product Code: 80-1047 i) Trauma and First Aid Kit Hard Case, Class B, with Bleeding Control Dressing; Kit Product Code: 80-1048 j) Micro individual first aid kit; Kit Product Code: 82-0002 k) Individual Aid Kit; Kit Product Code: 85-0404 l) KMBR HII Kit; Kit Product Code: 85-0757 m) Compact Officer Response Emergency Kit; Kit Product Code: 85-0834 n) Public Access Bleeding Control Twin Pack, Basic; Kit Product Code: 80-0951 o) Public Access Bleeding Control Twin Pack, Intermediate; Kit Product Code: 80-0952 p) Public Access Bleeding Control Twin Pack, Advanced BCD; Kit Product Code: 80-0953 q) Trauma and First Aid Kit; Kit Product Code: 80-1033 r) Trauma and First Aid Kit Hard Case; Kit Product Code: 80-1034 s) Tactical Quick Reaction Individual first aid kit; Kit Product Code: 85-1128 t) M-FAK Kit with S-Rolled Gauze; Kit Product Code: 85-1502 u) Public access individual bleeding control kit; Kit Product Code: 85-1574 v) Emergency Trauma Bleeding control pack; Kit Product Code: 85-1583 w) Bleeding control Kit; Kit Product Code: 85-1759 x) TORK Kit; Kit Product Code: 85-1907 y) Black scout survival IFAK individual first aid kit; Kit Product Code: 85-1942 z) Texas water first aid kit; Kit Product Code: 85-1953 aa) Crisis Ki; Kit Product Code: 85-1970 ab) ALE IFAK individual first aid kit; Kit Product Code: 85-2150 ac) RACH regional advisory council hemorrhage kit; Kit Product Code: 85-2176 ad) Triad Medical's SRAK student response aid kit; Kit Product Code: 85-2327 ae) ODIN medical EMT kit; Kit Product Code: 85-2425 af) ODIN medical AEMT kit; Kit Product Code: 85-2426 ag) Henry Schein public access individual bleeding control kit; Kit Product Code: 85-2430 ah) Henry Schein public access individual bleeding control kit; Kit Product Code: 85-2432 ai) Warrior Poet society Public access individual bleeding control kit; Kit Product Code: 85-2539 aj) Spec Train Compact Carry kit; Kit Product Code: 85-2833 ak) Belfast FD resupply kit; Kit Product Code: 85-2886 al) Trauma and First Aid Kit; Kit Product Code: 80-1045 am) Trauma and First Aid Kit Hard Case Class A, with Bleeding Control Dressing; Kit Product Code: 80-1046 an) M-FAK Kit; Kit Product Code: 85-2920 ao) IFAK individual first aid kit; Kit Product Code: 85-3022 ap) Bleeding control kit; Kit Product Code: 85-3046 aq) Individual first aid kit allegiance holster company; Kit Product Code: 85-3050 ar) RAC-PAK; Kit Product Code: 85-3052 as) Bleeding control E.F.A.K enhanced first aid kit; Kit Product Code: 85-3067 at) Bleeding control E.F.A.K enhanced first aid kit; Kit Product Code: 85-3068 au) Bleeding control E.F.A.K enhanced first aid kit; Kit Product Code: 85-3069 av) Task Force 6 resupply kit; Kit Product Code: 85-3078 aw) PABC Kit; Kit Product Code: 85-3082 ax) MCC IFAK Small Supply Kit; Kit Product Code: 85-3084 ay) MCC IFAK Large Supply Kit; Kit Product Code: 85-3085

    FDA Enforcement
    Class II ·Terminated·North American Rescue LLC.·October 7, 2020

    Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults. Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* MULTI-PORT, DSY, ENDO 10FR; b. HALYARD* MULTI-PORT, DSY, ENDO 12FR; c. HALYARD* MULTI-PORT, DSY, ENDO, MDI 12FR; d. HALYARD* MULTI-PORT, DSY, ENDO 14FR; e. HALYARD* MULTI-PORT, DSY, TRACH 14FR; f. HALYARD* MULTI-PORT, DSY, TRACH, WP 14FR; g. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; h. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; i. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; j. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; k. HALYARD* MULTI-PORT, DSY, ENDO, MDI 16FR;

    FDA Enforcement
    Class II ·Terminated·Halyard Health, Inc·April 25, 2018

    bvi Beaver Xstar Safety Slit Knife: (a) REF 378214, 1.4mm, 45o Bevel Up (b) REF 378215, 1.50mm, 45o Bevel Up (c) REF 378217, 1.7mm, 45o Bevel Up (d) REF 378218, 1.8mm, 45o Bevel Up (e) REF 378220, 2.0mm, 45o Bevel Up (f) REF 378222, 2.2mm, 45o Bevel Up (g) REF 378223, 2.3mm, 45o Bevel Up (h) REF 378224, 2.4mm, 45o Bevel Up (i) REF 378227, 2.75mm, 45o Bevel Up (j) REF 378228, 2.8mm, 45o Bevel Up (k) REF 378230, 3.0mm, 45o Bevel Up (l) REF 378232, 3.2mm, 45o Bevel Up (m) REF 378822, 2.2mm, 45o Double Bevel (n) REF 378824, 2.4mm, 45o Double Bevel (o) REF 378825, 2.5mm, 45o Double Bevel (p) REF 378826, 2.65mm, 45o Double Bevel (q) REF 378827, 2.75mm, 45o Double Bevel (r) REF 378828, 2.8mm, 45o Double Bevel (s) REF 378829, 2.85mm, 45o Double Bevel (t) REF 378830, 3.0mm, 45o Double Bevel (u) REF 378832, 3.2mm, 45o Double Bevel (v) REF 370145, 2.5mm, 45o Bevel Up (w) REF 370146, 2.6mm, 45o Bevel Up (x) REF 373025, kojo, 2.5mm, 45o Bevel Up (y) REF 373032, kojo, 3.2mm, 45o Bevel Up Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018

    Hip Components: INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers: W07335080 and X06391225 INSERT MOBILE "COLLEGIA" TAILLE 60*28, OT22C60, Lot Number: X06391226 TETE INOX "COLLEGIA" T 28/0 CONE 6 DEG. -N30NW-, OT32H28, Lot Numbers: 068573172 and X03396534 PROFEMUR(R) Z FEMORAL STEM S 1 CEMENT LESS, PHA00232, Lot Number: X05420041 PROFEMUR(R) Z FEMORAL STEM S 5 CEMENT LESS, PHA00240, Lot Number: V03156757 PROFEMUR(R) Z FEMORAL STEM S 8 CEMENT LESS, PHA00246, Lot Number: X05410982 PROFEMUR(R) Z FEMORAL STEM S 9 CEMENT LESS, PHA00248, Lot Numbers: V01132375, W03314591, X01383213, X02388533, X03396459, X04401274, and X07428776 REVISION SHELL "PROCOTYL(R) E" SIZE 52/60 G1 T/P COATED, PHA00370, Lot Number: X10410887 REVISION SHELL "PROCOTYL(R) E" SIZE 54/62 G1 T/P COATED, PHA00372, Lot Number: X05391267 REVISION SHELL "PROCOTYL(R) E" SIZE 56/64 G1 T/P COATED, PHA00374, Lot Number: X10418370 REVISION SHELL "PROCOTYL(R) E" SIZE 60/68 G2 T/P COATED, PHA00378, Lot Number: X10410890 REVISION SHELL "PROCOTYL(R) E" SIZE 62/70 G2 T/P COATED, PHA00380, Lot Number: X04391099 REVISION SHELL "PROCOTYL(R) E" SIZE 64/72 G2 T/P COATED, PHA00382, Lot Numbers: V07227366, X01372961, X02383420, and X10410892 REVISION SHELL "PROCOTYL(R) E" SIZE 66/74 G3 T/P COATED, PHA00384, Lot Numbers: X05391100 and X05391265 REVISION SHELL "PROCOTYL(R) E" SIZE 68/76 G3 T/P COATED, PHA00386, Lot Number: X01372963 STEM REVISION "PROFEMUR(R) Z" SIZE 3, PHA00606, Lot Numbers: X01399395, X03393766, and X04393775 STEM REVISION "PROFEMUR(R) Z" SIZE 4, PHA00608, Lot Numbers: X02399397, X03393767, and X04393776 STEM REVISION "PROFEMUR(R) Z" SIZE 5, PHA00610, Lot Numbers: X03393768, X03399398, X03400451, X04393777, and X04400452 STEM REVISION "PROFEMUR(R) Z" SIZE 6, PHA00612, Lot Numbers: W12238302, X03393769, X03399400, X03400453, X04393778, and X04400454 STEM REVISION "PROFEMUR(R) Z" SIZE 7, PHA00614, Lot Numbers: X01238303, X03393770, X03399401, X03400455, X04393779, and X04400456 STEM REVISION "PROFEMUR(R) Z" SIZE 8, PHA00616, Lot Numbers: X01238304, X01399402, X03393771, X03400458, X04393780, and X04400459 STEM REVISION "PROFEMUR(R) Z" SIZE 9, PHA00618, Lot Numbers: X01238305, X03393772, X03399404, and X04393781 STEM REVISION "PROFEMUR(R) Z" SIZE 10, PHA00620, Lot Numbers: X02399405, X03393773, and X04393782 STEM REVISION "PROFEMUR(R) Z" SIZE 11, PHA00622, Lot Numbers: X02377571, X03393774, and X04393783 CROCHET POUR COTYLE "PROCOTYL(R) E" L=18 (VERSION 3, PHA01106, Lot Numbers: V0181677, X03391269, and X03396706 CROCHET POUR COTYLE "PROCOTYL(R) E" L=23 (VERSION 3, PHA01107, Lot Numbers: U0366131, V0271861, W11376812, and X03391270 ILIAC PLATE "L" SHAPE "PROCOTYL(R) E" LEFT, PHA01110, Lot Number: X05420073 ILIAC PLATE "T" SHAPE "PROCOTYL(R) E" LEFT, PHA01120, Lot Number: X03396709 ILIAC PLATE "T" SHAPE "PROCOTYL(R) E" RIGHT, PHA01122, Lot Numbers: W07327875, X03391271, and X06401587 ILIAC PLATE DOUBLE "PROCOTYL(R) E" LEFT 4 HOLES, PHA01134, Lot Number: X03396707 ILIAC PLATE DOUBLE "PROCOTYL(R) E" RIGHT 4 HOLES, PHA01144, Lot Number: X03396708 ILIAC PLATE DOUBLE "PROCOTYL(R) E" RIGHT 5 HOLES, PHA01145, Lot Number: X03396359 PROFEMUR(R) NECK NEUTRALSHORT SHORT, PHA01202, Lot Numbers: U0781477, V02143965, V05185849, and X06420151 PROFEMUR(R) NECK NEUTRAL LONG, PHA01204, Lot Numbers: U0671647 and X03396401 PROFEMUR(R) NECK A/R VAR/VAL 2 SHORT, PHA01212, Lot Numbers: U0681198, U1185239, W12383174, X01388472, X02396405, X04401230, and X05418352 PROFEMUR(R) NECK A/R VAR/VAL 2 LONG, PHA01214, Lot Numbers: W07334963, W09359069, X02388473, X02396406, X05401242, and X05418353 PROFEMUR(R) NECK A/R VAR/VAL 1 SHORT, PHA01222, Lot Numbers: W09359061, X03396407, X04401231, X10420159, and X10428842 PROFEMUR(R) NECK A/R VAR/VAL 1 LONG, PHA01224, Lot Numbers: U1185241, V06215432, X01388475, X02396408, X04401232, X05418355, and X10420160 PROFEMUR(R) NECK 8DG A/R SHORT, PHA01232, Lot Numbers: V0821

    FDA Enforcement
    Class II ·Terminated·Wright Medical Technology Inc·November 7, 2012

    Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product Name (Model Number): A. 3.0T MR750 32CH (911000-3); B. 3.0T MR750W (5911000-3, 5481490-2, 5499460-7, 5499460-10, 5373011-3, 5352293, 5911000-3); C. 3.0T MR750W GEM (5499460-10, 5481490-2); D. 3.0T MR750W GEM ENAB (5911000-3); E. 3.0T MR750W GEM ENABLED (5352293, 5481490-2, 5481490-2, 5396469-3, 2394952-100, 5911000-3, 5373011-3); F. 3.0T MR750W GEM ENABLED PLU (5352293); G. 3.0T MR750W GEM ENABLED PLUS (5352293, 5499460-10); H. 3.0T MR750W W GEM (5352293, 5911000-3); I. 3.0T MR750W WITH GEM (5481490-2, 5911000-3); J. 3-0T MR750 32 CHANNEL (5352293); K. 3-0T MR750W FUTURE GEM CAPABLE (5352293, 5911000-3, 5499460-7); L. 3-0T MR750W GEM (5495558, 5352293); M. 3-0T MR750W GEM ENABLED (5911000-3, 5352293, 2394952-100, 5481490-2, 5499460-7, 5373011-3, 5495558, 5481490, 5396469-3, 5481490-3); N. 3-0T MR750W GEM ENABLED PLUS (5911000-3, 5352293, 5499460-10, 5481490-2); O. 3-0T MR750W NON GEM (5911000-3); P. 3T 750W (5921000-2, 5911000-3, 5396469-3, 5352293, 5481490-2, 5481490-3); Q. DISCOVERY MR 750W 3.0T (5481490-2, 5911000-3, 5499460-10); R. DISCOVERY MR750W (5911000-3); S. DISCOVERY MR750W 3 (5481490-2, 5911000-3); T. DISCOVERY MR750W 3T (5911000-3, 5396469-3, 5373011-3, 5481490-2); U. DISCOVERY MR750W GEM (5396469-3, 5352293); V. DISCOVERY MR750W WITH GEM (5911000-3); W. MR 3.0T MR750 W (5352293); X. MR 3.0T MR750W GEM ENABLED (5911000-3, 5352293); Y. MR 3-0T MR750W (5911000-3); Z. MR DISCOVERY 750W GEM (5911000-3); AA. MR OPTIMA MR750W 3.0T (5911000-3); BB. MR750W (5911000-3); CC. MR750W GEM ENABLED (5911000-3, 5499460-7); DD. MR750W GEM ENABLED PLUS (5352293); EE. MR750W PGR 32-CHANNEL (5911000-3); FF. 3.0T MR750W GEM ENAB (5911000-3) Product Usage: The Discovery MR750w 3.0T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Discovery MR750w 3.0T system reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance..

    FDA Enforcement
    Class II ·Terminated·GE Medical Systems, LLC·October 3, 2018

    TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box.

    FDA Enforcement
    Class I ·Terminated·Oscor, Inc.·November 14, 2018

    IMPLANTE DE ORTHOPEDIA - ( I) CAUTERY T IP POLI SHER LIF ( I) BAG SUTURE FLORAL LIF ( I) TUBE SUCTION CONNECT \14'' X 12' LIF ( I) BAG GLASSINE LIF (2) LITE GLOVE LIF (2) TABLE COVER 50" X 90" REINFORCED LIF ( I) MAYO STAND COVER REINFORCED LIF (5) TOWEL ABSORBENT 15" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF (2) DRAPE SHEET 70" X I 00" LIF (5) LAP SPONGES PRE-WASH 18" X 18" XRD L/F ( I) MAYO TRAY LARGE LIF ( I) DRAPE TOP WITH ADHESIVE LIF ( I) SKIN STAPLE 35 WIDE LIF ( I) BULB SYRINGE 60cc LIF ( I) UTILITY BOWL 16oz L/F (2) UTILITY BOWL 32oz L/F ( I) INCISION DRAPE 23" X I 7" L/F (I) SKIN MARKER WITH RULER LIF ( I) U-DRAPE 54" X 72" W/TAPE SPLIT 6" X 2 1" LIF (2) ABDOMINAL PAD 8" X 7.5" L/F ( I) YANKAUER SUCTION TUBE W/0 VENT L/F (I) DURAPREP SURGICAL SOLUTION 26ML LIF ( I) SURGICAL BLADE # 10 STAINLESS STEEL (I) SPLIT SHEET W/ADH 108" X 77"" STD SMS LIF ( I) IMP. STOCKINETTE LIF (I) *Pr. SURGEON NEUTRALON GLOVE #7 ~ LATEX ( I) *Pr. SURGEON NEUTRALON GLOVE #8 LATEX (I) *Pr. SURGEON NEUTRALON GLOVE #8 ~ LATEX (I) SURGEON GOWN REINF. T/WRAP X-LARGE LIF (2) IMP. GOWN REINFORCED X-LARGE SMS LIF (I) PENCIL CAUTERY ROCKER SWITCH LIF (I) SURGICAL BLADE #20 STAINLESS STEEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    NEURO SPINE PACK , CODE 900-2765 CONTENTS: (l ) DRAPE INCISION 23" X 1 7" (I) SCALPEL W/HANDLE # 15 S/STEEL (I) INSTRUMENT POUCH 7 X 1 1 2 COMPART (I) Pk. STRIP SURGICAL W' X 6" (I) CAUTERY PENCIL HAND SWITCHING LIF (4) UTILITY DRAPE W/TAPE L/F (I) SCALPEL W/HANDLE # 10 S/STEEL (I) TUBE SUCTION CONNECT W' X I 2' LIF (I) SKIN MARKER W/RULER (2) SPECIMEN CONTAINER4oz W/LID & LABEL (I) SOLUTION SURGICAL DURAPREP 26ML LIF (I) YANKAUER SUCTION TUBE W/0 VENT LIF (I) MAYO TRAY LARGE (2) NEEDLE & BLADE COUNTER lOc MAG/CLEAR (I) DRAPE INCISE ANTIMICROBIAL 23" X 1 7" LIF (2) SYRINGE I Occ W/0 NEEDLE LUER LOCK LIF (I) J VAC RESERVOIR 300ML (2) LITE GLOVE LIF (2) CAUTERY TIP POLISHER LIF (2) TABLE COVER BTC 77" X 110" HD FULL L/F (20) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (4) TOWELS ABSORBENT 1 5" X 20" LIF ( I ) DRAPE T LAPAROTOMY 102" X 78" X 1 21" STD SMS (5) LAP SPONGE PREWASH 18" X 18" XRD LIF ( I) SUTURE BAG FLORAL (5) DRAPE 'l'4 ECONOMY 53" X 77" LIF (3) GOWN IMPERVIOUS EXTRA REI NF. LGE T/WRAP (I) UTILITY BOWL 1 6oz LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    EAR PACK CONTENTS: (I) CAUTERY PENC IL ROCKER SW I TI-I CH ( I ) EMESIS BASIN l Oin 700cc (2) LABEL FOR SKIN MARKERS ( I) NEEDLE HYPODERMIC 1 80 X I Y, ( I) WASI-l BASIN ROUND 6QT (I) INSTRUMENT POUCH 7 X I I 2 COMPART (I) STRIP STER I CLOSURE W' X 4" LIF (I) SYRINGE 3cc W/0 NEEDLE LILOCK L/F (2) SY RI NGE I ML W/0 NEEDLE LILOCK LIF ( I ) CAUTERY POLISHER TI P LIF ( I) SH EET ENT SPLIT 11 0 X 77 (2) LITE GLOVE (2) NEEDLE H YPODERM IC 27G X I \!..'' (1 2) TOWELS CLOTH HUCK (BLUE) ( I ) TUBE SUCTION CONNECT.'!." X 12' L/F ( I ) EAR ULCER SYRINGE 2oz LIF ( I ) TABLE COYER REINFORCED 50" X 90" LIF ( I ) UTILITY BOWL 1 6oz LIF (4) COTrON APPLICATOR 6" WOOD ( I ) INSTRUMENT WIPE I MM 8.25 X 8.25 ( I ) MAYO STAND COYER REINFORCED LIF ( I ) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF ( I ) SKIN MARK ER W/R ULER ( I ) SYRINGE IOcc W/0 NEEDLE LILOCK LIF ( I ) TRAY MAYO SMALL ( I ) SYRING E IOcc TI P CONTROL LILOCK LIF ( I ) DRAPE MICROSCOPE ZEI SS ( I ) TOWELS ABSORBENT 1 5'' X 20" LIF ( I ) TIME OUT BEACON NON WOV EN ST LIF ( I ) BLADE M INUATURE CARBON STEEL ( I 0) GAUZE SPONGE 4" X 4" 1 6PLY XRD LIF ( I ) NEEDLE BLUNT FI LL 1 80 X I Y, (2) SCALPEL SAFETY WEIGHTED # 1 5 ( I ) GOWN SURG, I MP ER. M I CROCOOL LG E (2) GOWN XL SURG ICAL MICROCOOL ( I ) MERLINO SKIN PREP APPLIC. 39ML LIF ( I ) WRAPPER 24" X 24" WET SKIN PACK CONTA INING: ( I ) WRAPPER 30" X 30" ( I ) TRAY 3/COMPARTM ENT ( I ) PYP SCRUB SOLUTI ON 4oz. BOTrLE (3) TI P ABSORBENT APPLICATOR STICK SPONGE (3) TOWELS ABSORBENT 15" X 20" L/F (6) SPONGE WING SMALL LIF (2) GLOVE MED FREETOUCI-1 VYN I L P/F (2) COTrON APPLICATOR 6" WOOD Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    Laparotomy Pack, 900-2516, pack contains: ( I) TABLE COVER44" X 90" ( I) CAUTERY PENCIL PUSH BOTTOM (4) TOWELS ABSORBENT 15" X 20" L/F ( I) BULB SYRINGE 60cc LIF (4) DRAPE UTILITY WIT APE LIF (I) SKIN MARKER W/RULER ( I) SUTURE BAG FLORAL LIF ( I) Y ANKAUER SUCTION TUBE W/0 VENT LIF (2) COUNTER NDL /BLADE IOc MAG/CLEAR ( I) GOWN XL SMS IMPERV. REINFORCED LIF (5) LAP SPONGE PREWASH 18" X 18" XRD LIF ( I) GOWN SURG REINFORCED. LGE T/WRAP LIF ( I) TUBE SUCTION CONNECT W' X 12' LIF (2) LITE GLOVE LIF ( 10) GAUZE SPONGE4" X 4" 16PLY XRD LIF (2) DRAPE SHEET 41" X 58" SMS LIF ( I) CAUTERY TIP POLISHER LIF ( I) MERLING SKIN PREP APPLIC. 39ML LIF ( I) UTILITY BOWL PINT 16oz LIF ( I) SKIN STAPLE 35 WIDE LIF ( I) UTILITY BOWL QUART 32oz LIF ( I) BLADE SURGICAL II CARBON STEEL ( I) TRAY MAYO SMALL ( I) BLADE SURGICAL 20 CARBON STEEL ( I) MAYO STAND COVER REINFORCED LIF ( I) DRAPE LAPAROTOMY 100" X 72" X 124" W/POUCH Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014