37 results
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16ms
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Sources: EU EUDAMED, US FDA
PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, STERILE 1 EA, INTRODUCER SHEATH KIT, 7 FR W/.035 SHORT GUIDEWIRE, STERILE 1 EA., PREFILLED, STERILE FIELD SALINE SYRINGE, 10 ML, 4 EA, CLAMP, 5 FR, STERILE, 1 EA, SCALPEL, #11SS, STERILE, 1 EA, SUTURE, NYLON, 18", 2-0, REVERSE CUTTING, STERILE 1 EA, THREE QUARTER DRAPE, STERILE 1 EA, INSERT, SALINE 1 EA, INSERT, CLAMP 1 EA UDI: (01) 0 0863092 00010 1
FDA Enforcement
Class II
·Terminated·Prytime Medical Devices, Inc.·February 17, 2021
Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
FDA Enforcement
Class II
·Terminated·Covidien LLC·November 16, 2016
Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
FDA Enforcement
Class II
·Terminated·Covidien LLC·November 16, 2016
GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1. TRAY, PAC, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 2. TRAY, PAC, VEN LP, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 3. TRAY, PAC II, VEN, 2.8MM, CS, 9FR/INTRO 1/EA; 4. TRAY, PAC II, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 5. TRAY, PAC II, VEN, PU, 2.6MM, UL, 8.5FR/INTRO 1/EA; 6. TRAY, PAC II, VEN, PU, 2.6MM, PRE-AY, 8.5FR/INTRO 1/EA; 7. TRAY, PAC II, VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO, VALVED 1/EA; 8. TRAY, PAC II, VEN LP, PU, 1.9MM, UL, 6FR/INTRO, VALVED 1/EA; 9. TRAY, PAC II, VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO 1/EA; 10. TRAY, PAC II, VEN LP, PU, 2.6MM, PRE-AY, 8.5 FR/INTRO 1/EA; 11. TRAY, PAC II, VEN LP, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 12. TRAY, PROPORT, PLASTIC, 2PC, STD, SGL LMN, 1.0, PU 1/EA; 13. TRAY, PROPORT, PLASTIC, 2PC, STD, SGL LMN, 1.6, PU 1/EA; 14. TRAY, PROPORT, PLASTIC, 2PC, LP, SGL LMN, 1.6, PU 1/EA; 15. TRAY, PROPORT, PLASTIC, 2PC, LP, SGL LMN, 1.0, PU 1/EA; 16. TRAY, PROPORT, PLASTIC, 2PC, LP, SGL LMN, 1.0, SIL 1/EA; 17. TRAY, POWER PAC, VEN, TI, PU, 2.6MM, UL, 8.5 FR/INTRO 1/EA; 18. TRAY, POWER PAC, VEN, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 19. TRAY, POWER PAC, VEN LP, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 20. TRAY, POWER PAC II, VEN, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 21. TRAY, POWER PAC II, VEN, PU, 2.6MM, UL 8.5 FR/INTRO 1/EA; 22. TRAY, POWER PAC II, VEN, PU, 2.6MM, PRE-AY, 8.5 FR/INTRO 1/EA; 23. TRAY, POWER PAC II, VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO 1/EA; 24. TRAY, POWER PAC II, VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED 1/EA; 25. TRAY, POWER PAC II, VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED 1/EA; 26. TRAY, POWER PAC II, VEN, PU, 1.9MM, UL, 6 FR/INTRO, VALVED 1/EA; 27. TRAY, POWER PAC II, VEN, LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED 1/EA; 28. TRAY, POWER PAC II, VEN LP, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 29. TRAY, POWER PAC II, VEN LP, PU, 1.9MM, PRE-AY, 6 FR/INTRO 1/EA; 30. TRAY, POWER PAC, PASPORT T2, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 31. TRAY, PAC II, DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO 1/EA; 32. TRAY, POWER PAC II, DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO 1/EA; 33. TRAY, POWERPAC II, DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO 1/EA; 34. TRAY, POWER PAC II, DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO, VALVED 1/EA;
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·October 30, 2019
Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); c. VEN LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED (1/EA); d. DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO (1/EA); e. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO (1/EA); f. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO, VALVED (1/EA); g. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO, VALVED (1/EA)
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·March 21, 2018
PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO (1/EA); c. DL, LP, PU, 3.2MM, WING-LOCK, 10FR/INTRO (1/EA)
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·March 21, 2018
Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2104 Medium 8 x 15 Inch 1/EA, 24 ENCA ASL 2105 Large 8.5 x 17.5 Inch 1/EA, 24 ENCA ASL 2106 Extra-Large 9 x 20 Inch 1/EA, 24 ENCA ASL 2150 Universal 7 x 18 Inch 1/EA, 24 ENCA Medical - An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
FDA Enforcement
Class II
·Terminated·Owens & Minor Distribution, Inc.·December 28, 2016
Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care
FDA Enforcement
Class II
·Terminated·Breas Medical AB·July 22, 2015
Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 65 ventilators - Product Usage: The protective cover is intended for additional protection of the Vivo 50, Vivo 55, Vivo 60 and Vivo 65 ventilators during transportation, and in hospital, institutional, and home care environments. It can be used while the Vivo ventilators is operating, for example mounted on a wheelchair, in a personal vehicle, or carried by hand. The device is not to be used with the protective cover while positioned in a warm place, such as in direct sunlight or close to a radiator. The protective cover includes the following features: transparent window for accessing front panel and buttons; port for patient circuit, cables, O2 inlet, and standby button; cooling air inlet; patient air inlet; straps for safe mounting; and cooling air outlet.
FDA Enforcement
Class II
·Terminated·Breas Medical, Inc.·March 4, 2020
Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384
FDA Enforcement
Class II
·Terminated·Breas Medical, Inc.·April 20, 2022
Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·February 21, 2018
SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument.
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·February 5, 2014
Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·May 17, 2017
KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation devices.
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·February 11, 2015
Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·January 24, 2018
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA
FDA Enforcement
Class II
·Terminated·Sorin Group USA, Inc.·August 9, 2017
NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE
FDA Enforcement
Class II
·Terminated·Sorin Group USA, Inc.·August 9, 2017
SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA
FDA Enforcement
Class II
·Terminated·Sorin Group USA, Inc.·August 9, 2017
SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA
FDA Enforcement
Class II
·Terminated·Sorin Group USA, Inc.·August 9, 2017
STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, Rx Only, 1 EA
FDA Enforcement
Class II
·Terminated·Sorin Group USA, Inc.·August 9, 2017