BEUDAMED
    455 results · 19ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·July 10, 2024

    Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR S 1 Bowl Fluid Containment W/LI 1 Cover Probe 6 X 48 NS 2 Gown surgical STD XLG NR 1 Needle RB 18x1.5 1 Spike Bag Decanter 2 Syringe 20CC L/L 1 Utility Marker Permanent U 1 Bowl Denture Cup 8 oz (250C 4 Clamp Towel 2.5 1 Drape Angio/FEM 87X124 W/2 V 1 Angio Tubing HP 10 W/ROT M/L 1 Needle RB 22 X 1.5 30 Sponge 4 X 4 X 12 Plain 10 Towel or Blue 1 Prep Ultrasound Gel Packet 1 Bowl Guidewire 80 Oz (2500C 1 Cover Backtable 50 X 90 Zoni 1 Instr Forcep Kelly Strt 5.5 10 Label Custom 1 Counter Needle Nest 6 Syringe 10CC L/L 1 Bag Band Dome 22 2 Prep Chloraprep One-Step 3

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·June 23, 2021

    Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7046; endoscopic surgical device

    FDA Enforcement
    Class II ·Ongoing·Carefusion 2200 Inc·August 23, 2023

    Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7071; endoscopic surgical device

    FDA Enforcement
    Class II ·Ongoing·Carefusion 2200 Inc·August 23, 2023

    Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7043; endoscopic surgical device

    FDA Enforcement
    Class II ·Ongoing·Carefusion 2200 Inc·August 23, 2023

    Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number 285330S). Screws are provided in different diameters and lengths and are used to anchor various sizes and shapes of bone fixation plates when treating bone fractures or reconstruction of the ankle, foot or hand.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·June 11, 2014

    Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75).

    FDA Enforcement
    Class II ·Terminated·Signal Medical Corporation·October 29, 2014

    Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire 80 oz 4 Clamp Towel 2.5 1 Cover Probe 6X48 NS 2 Gown Surgical STD XLG NR 16 Label Custom 1 Counter Needle Nest 40 Sponge 4x4x12 plain 1 Syringe 10cc control polyc 1 Bag Band Dome 22 2 Prep ChloraPrep One-Step 3 1 Dressing Transparent 4 X 4 1 Glove Perry 6.5 PF Steril 1 Bowl Fluid Containment W/Li 1 Cover backtable 50 X 90 Zon 1 Cup medicine 2 oz clear 2 Stopcock 3 way rot m/l/l 2 Needle RB 22x 1.5 1 Spike Bag decanter 6 Syringe 10cc L/L 10 Towel or Blue 2 Bag Band 36 X 50 W/TP 1 Prep Ultra Sound Gel Packet 1 Bowl Denture Cup 8 oz (250C 1 Bowl 32 oz (1000CC) 1 Cover Set UP 54X90 1 Instr Forcep Kelly Strt 5.5 1 Angio Tubing HP 10 W/ROT M/L 1 Needle Introducer 21G 1 Dressing Telfa 3X4 2 Syringe 20cC L/L 1 Guidewire Nitinol .018X45CM 1 Drape Angio 80 X 125 W/2 WIN 1 Introducer 5F X 10CM Stiff.

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·June 23, 2021

    RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part number 28-M4-34-100-34U; (b) Part number 28-M4-30-095-30U; (c) Part number 28-M4-46-155-46U; (d) Part number 28-M4-32-155-32S; (e) Part number 28-M4-36-250-32S; (f) Part number 28-M4-38-145-34S; (g) Part number 28-M4-38-190-38S; (h) Part number 28-M4-44-105-44S; (i) Part number 28-N4-22-099-22S; (j) Part number 28-N4-22-159-22S; (k) Part number 28-N4-24-099-24S; (l) Part number 28-N4-28-204-24S (m) Part number 28-N4-30-164-30U; (n) Part number 28-N4-32-164-28S; (o) Part number 28-N4-34-154-34U; (p) Part number 28-N4-34-209-30S; (q) RELAY PRO Custom-Made Device, REF 28NC36N19038S2590, part number 28-CMP-3062-NC; and (r) RELAY PRO Custom-Made Device, REF 28MC36A17536S2390, part number 28-CMP-3074-MC;

    FDA Enforcement
    Class II ·Completed·Bolton Medical Inc.·April 3, 2024

    L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3) 880-321/12 (Sz. 1-2 - cemented sm), (4) 880-321/22 (Sz. 1-2 - cemented lg), (5) 880-323/13 (Sz. 3-4 - cemented sm), (6) 880-323/23 (Sz. 3-4 - cemented lg), (7) 880-325/13 (Sz. 5-6 - cemented sm), (8) 880-325/23 (Sz. 5-6 - cemented lg), (9) 880-327/13 (Sz. 7-8 - cemented sm), (10) 880-327/23 (Sz. 7-8 - cemented lg), (11) 880-329/13 (Sz. 9-10 - cemented sm), (12) 880-329/23 (Sz. 9-10 - cemented lg).

    FDA Enforcement
    Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·May 7, 2025

    1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182; 2. Guardia" Access Nano Embryo Transfer Catheter, Catalog Number: K-JETS-551910-L, Global Product Number: G24215; 3. Sydney IVF¿ Embryo Transfer Set, Product Number: K-JETS-7019-SIVF, Global Product Number: G18740

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·April 4, 2018

    Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246, Article Number A22-7107. For use in cardiopulmonary bypass

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiopulmonary Ag·June 20, 2018

    ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number: 01586287; SMN:10315522.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·March 11, 2015

    ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog number: 02177364; SMN: 10333111.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·March 11, 2015

    ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number: 02382928; SMN: 10310305.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·March 11, 2015

    Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80220; c) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 82020; d) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 87120; e) DLP¿ Curved Metal Tip Arterial Cannula 22 Fr. , Model Number 80222; f) DLP¿ Curved Metal Tip Arterial Cannula 22 Fr. , Model Number 87122; g) DLP¿ Curved Tip Arterial Cannula 20 Fr., Model Number 87220; h) DLP¿ Curved Tip Arterial Cannula 22 Fr., Model Number 87222; i) DLP" One-Piece Arterial Cannulae, Pediatric 6 Fr, Model Number 77006; j) DLP" One-Piece Pediatric Arterial Cannula 6 Fr, Model Number 77206; k) DLP" One-Piece Pediatric Arterial Cannula 8 Fr, Model Number 77008; l) DLP" One-Piece Pediatric Arterial Cannula 10 Fr, Model Number 77010; m) DLP" One-Piece Pediatric Arterial Cannula 10 Fr, Model Number 77110; n) DLP" One-Piece Pediatric Arterial Cannula 12 Fr, Model Number 77112; o) EOPA" Elongated One Piece Arterial Cannula 20 Fr., Model Number 77420; p) EOPA" Elongated One Piece Arterial Cannula 22 Fr., Model Number 77422; q) EOPA" Elongated One Piece Arterial Cannula 22 Fr., Model Number 77522; r) EOPA" Elongated One Piece Arterial Cannula 22 Fr., Model Number 77622; s) EOPA" Elongated One Piece Arterial Cannula 24 Fr., Model Number 77524; t) Select Series" Angled Tip Arterial Cannula 24Fr., Model Number 72424; u) Select Series" Straight Tip Arterial Cannula 20 Fr., Model Number 72120; v) Select Series" Straight Tip Arterial Cannula 24 Fr., Model Number 72224

    FDA Enforcement
    Class II ·Ongoing·Medtronic Perfusion Systems·May 22, 2024

    Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-32, j) 200-07-35, k) 204-21-13, l) 204-22-26, m) 208-23-18, n) 208-24-13

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·December 27, 2023

    Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; b) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; c) MINI MINOR AGH ASC PACK, kit number AGMM60M; d) OUTPATIENT PORT ACCESS KIT 307907, kit number AHPO55J; e) General Pack, kit number BBGP31C; f) FRACTURE TABLE PACK, kit number FDFT75N; g) Arthroscopy Pack, kit number HCAR04K; h) BARIATRIC PACK, kit number HGBA92F; i) LAPAROTOMY PACK, kit number HNLP12J; j) MIDLINE CHANGE KIT, kit number HSMD20E; k) Minor General, kit number JSMI10I; l) ENDO VASCULAR PACK, kit number LVEV61; m) MAJOR PACK, kit number LVMJ21; n) HEAD AND NECK PACK, kit number MMHN37F; o) KIT, MINOR U BAR, kit number MMNU34E; p) KIT, MAJOR UNIVERSAL, kit number MMUN28E; q) VAG PLASTY PACK, kit number OSVP16; r) DR L MAJOR, kit number SALM40H; s) DR L MAJOR, kit number SALM40I; t) MINOR BASIN SAH, kit number SAMB25E; u) MAJOR SAH, kit number SAMJ36G; v) MINOR PACK, kit number SMMN65; w) General Pack, kit number THGN59D; x) MINOR PACK, kit number TPMN15; y) MAJOR UNIVERSAL PACK, kit number TPUN48

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·February 7, 2024

    Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR; 2) SYRINGE 10ML CONTROL W/ROTATOR, Model Number: DYNJSYR10CWR; 3) SYR CONTROL PAD 12ML L/L, Model Number: DYNJSYR12CP; 4) TBG PRESS 72IN M/F ROT BRAID, Model Number: DYNJBRT72R; 5) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C; 6) SYRINGE 8ML CONTROL MLL, Model Number: DYNJSYR8C; 7) SYRINGE 12ML CONTROL MLL, Model Number: DYNJSYR12C; 8) SYR CONTROL PAD 10ML L/L ROT, Model Number: DYNJSYR10CRP; 9) SYR CONTROL PAD 12ML L/L ROT, Model Number: DYNJSYR12CRP; 10) CTRL SYRINGE 6ML RING ROT L/L, Model Number: DYNJSYRC6CWR

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·April 29, 2026

    Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e) 314-23-15, f) 314-24-22, g) 314-24-23, h) 314-24-24, i) 314-24-32, j) 314-24-33, k) 314-24-34, l) 314-24-35

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·December 27, 2023