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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers: a) REF 1-10013-109, SIZE 1-LEFT MED, 9MM; b) REF 1-10013-110, SIZE 1-LEFT MED, 10MM; c) REF 1-10013-111, SIZE 1-LEFT MED, 11MM; d) REF 1-10013-113, SIZE 1-LEFT MED, 13MM; e) REF 1-10013-159, SIZE 1-RIGHT MED, 9MM; f) REF 1-10013-160, SIZE 1-RIGHT MED, 10MM; g) REF 1-10013-161, SIZE 1-RIGHT MED, 11MM; h) REF 1-10013-163, SIZE 1-RIGHT MED, 13MM; i) REF 1-10013-209, SIZE 2-LEFT MED, 9MM; j) REF 1-10013-210, SIZE 2-LEFT MED, 10MM; k) REF 1-10013-211, SIZE 2-LEFT MED, 11MM; l) REF 1-10013-213, SIZE 2-LEFT MED, 13MM; m) REF 1-10013-259, SIZE 2-RIGHT MED, 9MM; n) REF 1-10013-260, SIZE 2-RIGHT MED, 10MM; o) REF 1-10013-261, SIZE 2-RIGHT MED, 11MM; p) REF 1-10013-263, SIZE 2-RIGHT MED, 13MM; q) REF 1-10013-309, SIZE 3-LEFT MED, 9MM; r) REF 1-10013-310, SIZE 3-LEFT MED, 10MM; s) REF 1-10013-311, SIZE 3-LEFT MED, 11MM; t) REF 1-10013-313, SIZE 3-LEFT MED, 13MM; u) REF 1-10013-359, SIZE 3-RIGHT MED, 9MM; v) REF 1-10013-360, SIZE 3-RIGHT MED, 10MM; w) REF 1-10013-361, SIZE 3-RIGHT MED, 11MM; x) REF 1-10013-363, SIZE 3-RIGHT MED, 13MM; y) REF 1-10013-409, SIZE 4-LEFT MED, 9MM; z) REF 1-10013-410, SIZE 4-LEFT MED, 10MM; aa) REF 1-10013-411, SIZE 4-LEFT MED, 11MM; bb) REF 1-10013-413, SIZE 4-LEFT MED, 13MM; cc) REF 1-10013-459, SIZE 4-RIGHT MED, 9MM; dd) REF 1-10013-460, SIZE 4-RIGHT MED, 10MM; ee) REF 1-10013-461, SIZE 4-RIGHT MED, 11MM; ff) REF 1-10013-463, SIZE 4-RIGHT MED, 13MM; gg) REF 1-10013-509, SIZE 5-LEFT MED, 9MM; hh) REF 1-10013-510, SIZE 5-LEFT MED, 10MM; ii) REF 1-10013-511, SIZE 5-LEFT MED, 11MM; jj) REF 1-10013-513, SIZE 5-LEFT MED, 13MM; kk) REF 1-10013-559, SIZE 5-RIGHT MED, 9MM; ll) REF 1-10013-560, SIZE 5-RIGHT MED, 10MM; mm) REF 1-10013-561, SIZE 5-RIGHT MED, 11MM; nn) REF 1-10013-563, SIZE 5-RIGHT MED, 13MM; oo) REF 1-10013-609, SIZE 6-LEFT MED, 9MM; pp) REF 1-10013-610, SIZE 6-LEFT MED, 10MM; qq) REF 1-10013-611, SIZE 6-LEFT MED, 11MM; rr) REF 1-10013-613, SIZE 6-LEFT MED, 13MM; ss) REF 1-10013-659, SIZE 6-RIGHT MED, 9MM; tt) REF 1-10013-660, SIZE 6-RIGHT MED, 10MM; uu) REF 1-10013-661, SIZE 6-RIGHT MED, 11MM; vv) REF 1-10013-663, SIZE 6-RIGHT MED, 13MM; Unicondylar knee prothesis

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·June 7, 2023

    CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU and display part numbers have been added as affected devices: (1) Part #2082294-001, FRU MP200 POWER SUPPLY ASSEMBLY; (2) Part #2082293-002-R, FRU MP200 CPU ASSEMBLY; (3) Part #2082293-002, FRU MP200 CPU ASSEMBLY; (4) Part #2071523-001, MP200 22 IN DISPLAY WITH TOUCH; (5) Part #2092930-001, DSP LCD 22 IN MED W/TCH W/DKST N AMR; (6) Part #2092930-002, DSP LCD 22 IN MED W/TCH W/DKST BRIT P/C; (7) Part #2092930-003, DSP LCD 22IN MED W/TCH W/DKST EURO P/C; (8) Part #2092930-004, DSP LCD 22IN MED W/TCH W/DKST ITA P/C; (9), Part #2092930-005, DSP LCD 22IN MED W/TCH W/DKST INDIAN P/C; (10) Part #2092930-006, DSP LCD 22IN MED W/TCH W/DKST ISREAL P/C; (11) Part #2092930-007, DSP LCD 22IN MED W/TCH W/DKST SWISS P/C; (12) Part #2092930-008, DSP LCD 22IN MED W/TCH W/DKST AUSTRL P/C; (13) Part #2092930-009, DSP LCD 22IN MED W/TCH W/DKST JPN; (14) Part #2092930-010, DSP LCD 22IN MED W/TCH W/DKST BRZL P/C; (15) Part #2092930-011, DSP LCD 22IN MED W/TCH W DKST ARGNT P C; (16) Part #2092930-012, DSP LCD 22IN MED W TCH W DKST DENMARK; (17) Part #2092930-013, DSP LCD22IN MED W TCH W DKST S AFRICA P C; and (18) Part #2092930-014, DSP LCD22IN MED W TCH W DKST CHINA P C.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·June 22, 2022

    Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are indicated for use as a diagnostic device. The purpose of the MED is to supply power to charge the magnet. MED is abbreviation for Magnet Energize Device

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Nederlands·May 8, 2019

    BIRMINGHAM HIP RESURFACING MODULAR HEAD, REF numbers: 74121238, MODULAR HEAD 38 MM -8MM 74121242, MODULAR HEAD 42 MM -8MM 74121246, MODULAR HEAD 46 MM -8MM 74121250, MODULAR HEAD 50 MM -8MM 74121254, MODULAR HEAD 54 MM -8MM 74121258, MODULAR HEAD 58 MM -8MM 74121338, MODULAR HEAD 3 8MM -4 (SHORT) 74121342, MODULAR HEAD 42 MM -4 (SHORT) 74121346, MODULAR HEAD 46 MM -4 (SHORT) 74121350, MODULAR HEAD 50 MM -4 (SHORT) 74121354, MODULAR HEAD 54 MM -4 (SHORT) 74121358, MODULAR HEAD 58 MM -4 (SHORT) 74121438, MODULAR HEAD 38 MM +0 (MED) 74121442, MODULAR HEAD 42 MM +0 (MED) 74121446, MODULAR HEAD 46 MM +0 (MED) 74121450, MODULAR HEAD 50 MM +0 (MED) 74121454, MODULAR HEAD 54 MM +0 (MED) 74121458, MODULAR HEAD 58 MM +0 (MED) 74121538, MODULAR HEAD 38 MM +4 (LONG) 74121542, MODULAR HEAD 42 MM +4 (LONG) 74121546, MODULAR HEAD 46 MM +4 (LONG) 74121550, MODULAR HEAD 50 MM +4 (LONG) 74121554, MODULAR HEAD 54 MM +4 (LONG) 74121558, MODULAR HEAD 58 MM +4 (LONG)

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew, Inc.·January 13, 2016

    Procedure packs: (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (2) Presource PBDS Cat. PG33BTO22, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (3) Presource PBDS Cat. PG33SROUB, Ohio State Univ Wexner Med Ctr, Kit, Robot Surg Onc, Sterile; (4) Presource PBDS Cat. PUMHCCESP, Southeast Hospital MHHS, Kit, Cystoscopy, SE, Sterile; (5) Presource General Laparoscopy Pack, Cat. SBA18GLEFF, St. Elizabeth Medical Center, Sterile; (6) Presource IUS Perc 1 Pk, Cat. SOTCGPPMEA, IU Health Methodist Hospital, Sterile; (7) Presource Cysto Pack, Cat. SOT18CYEFC, St. Elizabeth Medical Center; Sterile (8) Presource GU PUP Pack, Cat. SOT29GUHCD, Hillcrest Hospital, Sterile; (9) Presource PCNL Pack, Cat. SOT30PENBB, North Bay Regional Hlth Ctr, Sterile; (10) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO13, Ohio State Univ Wexner Med Ctr., Sterile; (11) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO15, Ohio State Univ Wexner Med Ctr., Sterile; (12) Presource PNL Cysto Pack, Cat. SOT51CPKOA, KP Oakland Med Center, Sterile; (13) Presource PNL Cysto Pack, Cat. SOT51CPK10, KP Oakland Med Center, Sterile; (14) Presource PCN Pack, Cat. SOT69PCKSA, KP Los Angeles Med Center, Sterile; (15) Presource Perc Neph Pack, Cat. SOT7APNLVB, Lehigh Valley Hospital, Sterile; and (16) Presource Cysto Pack, Cat. SOT73CPKSB, KP Zion Med Cntr, Sterile.

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·October 18, 2023

    MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.

    FDA Enforcement
    Class II ·Terminated·MED-EL Elektromedizinische Gereate, Gmbh·August 14, 2019

    MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; b. Mi1000 CONCERTO +FLEX28; c. Mi1000 CONCERTO PIN +FLEXsoft; d. Mil000 CONCERTO +Standard; e. Mil000 CONCERTO +Medium; f. Mi1000 CONCERTO PIN +Standard; g. M11000 CONCERTO +Compressed Product Usage: The Mi1000 CONCERTO Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.

    FDA Enforcement
    Class II ·Terminated·MED-EL Elektromedizinische Gereate, Gmbh·August 14, 2019

    Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits

    FDA Enforcement
    Class II ·Terminated·DeRoyal Industries Inc·July 25, 2012

    MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; c. SONATAti100 Standard Product Usage: The SONATATIi100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.

    FDA Enforcement
    Class II ·Terminated·MED-EL Elektromedizinische Gereate, Gmbh·August 14, 2019

    A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula sold under the Symmetry Surgical, CareFusion, and Ambler Surgical brand names.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·December 17, 2014

    Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW 22011 LL - SHUNT 22011 LL INTL ONLY ULTRA SM L-L 22011 M - SHUNT 22011 M INTL ONLY ULTRA SM MED 22017 B-L - SHUNT 22017 B-L ASSY US PER 90CM SM LOW 22017 B-M - SHUNT 22017 B-M ASSY US PER 90CM SM MED 22017B-LL - SHUNT 22017B-LL ASSY US PER 90CM SM LL 23093 - VALVE 23093 CONT. REG. LOW-LOW 27102 - VALVE 27102 CONTOURED SML LOW LOW 27553 M - VALVE 27553 M CSF-FLOW CNTRL SM EXTR MP 27643M - SHUNT 27643M ASSY SM PCATH130CM MED 27683M - SHUNT 27683M RG SNP PCATH90 PLI STD OE 42312 - VALVE 42312 SM CONTOURED LOW PRES IMP 42314- VALVE 42314 SM CONTOURED MED PRESS IMP 42316 - VALVE 42316 SM CONTOURED HIGH PRESS 42322 - VALVE 42322 CONTOURED REG LOW PRESS IMP 42324 - VALVE 42324 CONTOURED REG MED PRESS IMP 42326 - VALVE 42326 CONT HIGH PRESS IMP 42410 - VALVE 42410 ULTRA SMALL LOW-LOW 42414 - VALVE 42414 ULTRA SMALL MEDIUM PRESS IMP 42532 - VALVE 42532 BURR HOLE 12MM LOW PRESS IMP 42534 - VALVE 42534 BURR HOLE 12MM MED PRESS IMP 42536 - VALVE 42536 BURR HOLE 12MM HI PRESS IMP 42542 - VALVE 42542 BURR HOLE 16 MM LOW IMP 42544 - VALVE 42544 BURR HOLE 16MM MED PRESS IMP 42546 - VALVE 42546 BURR HOLE 16MM HI PRESS IMP 46564 - SHUNT 46564 CSF SNAP ASSY US MEDIUM 46622 - SHUNT 46622 CSF ASSY SMALL LOW CONT C/P 46624 - SHUNT 46624 CSF ASSY SMALL MED CONT C/P 46626 - SHUNT 46626 CSF ASSY SMALL HIGH CONT C/P 46642 - SHUNT 46642 ASSY REG LOW C/P-90CM 46644 - SHUNT 46644 ASSY REG MED C/P-90CM 46646 - SHUNT 46646 ASSY REG HIGH C/P-90CM 9003 A - KIT 9003 A INTL ONLY SHUNT CONT SM LO 9003 B - KIT 9003 B INTL ONLY SHUNT CONT SM ME 9003 C - KIT 9003 C INTL ONLY SHUNT CONT SM HI 9003 D - KIT 9003 D SHUNT INTL ONLY CONT REG L 9003 E - KIT 9003 E SHUNT INTL ONLY CONT REG M 9003 F - KIT 9003 F SHUNT INTL ONLY CONT REG H 9040 A - KIT 9040 A SHUNT INTL ONLY BH 12MM LOW 9040 B - KIT 9040 B SHUNT INTL ONLY BH 12MM MED 9040 C - KIT 9040 C SHUNT INTL ONLY BH 12MM HIGH 9040 D - KIT 9040 DSHUNT INTL ONLY BH 16MM LOW 9040 E - KIT 9040 E SHUNT INTL ONLY BH 16MM MED 9040 F - KIT 9040 A SHUNT INTL ONLY BH 12MM LOW 92322 - VALVE 92322 CSF CONT REG LOW BIO 92324 - VALVE 92324 CSF CONT REG MED BIO

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neurosurgery·February 24, 2021

    Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App; JT-200/ J TONG ASSEMBLY SML/MED; JT-210/ J TONG ONLY SML/MED; JT-400/ J TONG COMPONENT TRAY

    FDA Enforcement
    Class II ·Terminated·Ossur Americas·March 20, 2019

    Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334 (6 count) and UPC 675506804478 (12 count) - Product Usage: for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity.

    FDA Enforcement
    Class II ·Terminated·Clerio Vision·January 20, 2021

    Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK,MED CONC,SHORT,PEDI,7' TUB SC; HUD1042 O2 MASK,MED CONC,PEDI,7' TUB SC; HUD1930 O2 MASK,MED CONC,ADULT,7' TUB UC; HUDRHO41U MASK,OXYGEN,MEDIUM-CONCENTRATION,7,SC

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·January 14, 2026

    Product 37 consists of all product under product code: HSB and same usage: Item no: 225302055 INTERLOCKING IM SCREW LG 225303055 INTERLOCKING IM SCREW LG 225304055 INTERLOCKING IM SCREW LG 225304555 INTERLOCKING IM SCREW LG 225305055 INTERLOCKING IM SCREW LG 225305555 INTERLOCKING IM SCREW LG 225306055 INTERLOCKING IM SCREW LG 225306555 INTERLOCKING IM SCREW LG 225307055 INTERLOCKING IM SCREW LG 225307555 INTERLOCKING IM SCREW LG 225308055 INTERLOCKING IM SCREW LG 225308555 INTERLOCKING IM SCREW LG 225309055 INTERLOCKING IM SCREW LG 225302542 INTERLOCKING IM SCREW MED 225303042 INTERLOCKING IM SCREW MED 225303542 INTERLOCKING IM SCREW MED 225304042 INTERLOCKING IM SCREW MED 225304542 INTERLOCKING IM SCREW MED 225305042 INTERLOCKING IM SCREW MED 225305542 INTERLOCKING IM SCREW MED 225306042 INTERLOCKING IM SCREW MED 225306542 INTERLOCKING IM SCREW MED 225307042 INTERLOCKING IM SCREW MED 225307542 INTERLOCKING IM SCREW MED 225308042 INTERLOCKING IM SCREW MED 225308542 INTERLOCKING IM SCREW MED 225302037 INTERLOCKING IM SCREW SML 225302537 INTERLOCKING IM SCREW SML 225303037 INTERLOCKING IM SCREW SML 225303537 INTERLOCKING IM SCREW SML 225304037 INTERLOCKING IM SCREW SML 225304537 INTERLOCKING IM SCREW SML 225305037 INTERLOCKING IM SCREW SML 225305537 INTERLOCKING IM SCREW SML 225306037 INTERLOCKING IM SCREW SML 225306537 INTERLOCKING IM SCREW SML 225308537 INTERLOCKING IM SCREW SML Product Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

    FDA Enforcement
    Class II ·Terminated·Zimmer Manufacturing B.V.·March 23, 2016

    MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12", Sterile, Rx only, Distributed by Tanner Scientific, Sarasota, FGL 34243  Made in China.

    FDA Enforcement
    Class II ·Terminated·Global Healthcare Inc·September 28, 2016

    BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·January 22, 2025

    ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers: (a) 16037-64-01; MedNet 6.1 b) 16037-64-02; MedNet 6.1 c) 16037-64-03; MedNet 6.1 d) 16037-64-04; MedNet 6.21 The ICU Medical MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and MedNet compatible infusion pumps. The MMS provides trained healthcare professionals with the capability to send, receive, report, and store information from interfaced external systems, and to configure and edit infusion programming parameters. The MMS is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by a trained healthcare professional according to physician s orders.

    FDA Enforcement
    Class II ·Terminated·ICU Medical Inc·December 13, 2017

    Product 38 consists of all product under product code: HSB and same usage: Item no: 225303255 INTERLOCKING IM SCREW LG 225303555 INTERLOCKING IM SCREW LG 225303755 INTERLOCKING IM SCREW LG 225307055 INTERLOCKING IM SCREW LG 225302742 INTERLOCKING IM SCREW MED 225303242 INTERLOCKING IM SCREW MED 225307042 INTERLOCKING IM SCREW MED 225302737 INTERLOCKING IM SCREW SML 225303237 INTERLOCKING IM SCREW SML Product Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

    FDA Enforcement
    Class II ·Terminated·Zimmer Manufacturing B.V.·March 23, 2016

    MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque Stripe and Enteral Connector, 6.5Fr X 24" (60cm), REF 54-2465-R Product Usage: A Nasogastric/Oralgastric enteral feeding tube. The MED-RX Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician.

    FDA Enforcement
    Class II ·Terminated·Canadian Hospital Specialties·January 23, 2019