19 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U
FDA 510(k)
FDA Class 1
·General Hospital
N/A
FDA UDI
Tyber Medical, LLC·M695M1203360·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450192665·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450192344·
MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711
FDA 510(k)
FDA Class 2
·Microbiology
ENDOSCOPIC CAMERA MC404/C3
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PENUMBRA SMART COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·December 11, 2015
SUMMIT POR TAPER SZ7 STD OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·January 23, 2013
PINNACLE MTL INS NEUT36IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·October 3, 2012
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 20, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 26, 2014
FORCETRIAD
FDA Adverse Event
COVIDIEN VALLEYLAB·Product code GEI·May 27, 2011
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·October 3, 2012
22 G X 1.00 IN. BD INSYTE¿ PERIPHERAL VENOUS CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·August 2, 2017
1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·August 22, 2018
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit SKU Number: 65110351; 3. HEART CATH PACK-LF, Medline Kit SKU Number: DYNJ0373285M; 4. ANGIO DRAPE CARDIAC PACK, Medline Kit SKU Number: DYNJ51615P; 5. ANGIO DRAPE CARDIAC PACK, Medline Kit SKU Number: DYNJ51615R; 6. HEART RADIAL LAB PACK, Medline Kit SKU Number: DYNJ61982C; 7. HEART RADIAL LAB PACK, Medline Kit SKU Number: DYNJ61982D; 8. HEART ABLATION DRAPE PACK, Medline Kit SKU Number: DYNJ61984C; 9. TAVR PACK, Medline Kit SKU Number: DYNJ62310B; 10. HEART TAVR PACK, Medline Kit SKU Number: DYNJ65174G; 11. FEMORAL CARDIAC CATH, Medline Kit SKU Number: DYNJ66343A; 12. CARDIAC CATH PACK, Medline Kit SKU Number: DYNJ66693C; 13. TAVR PACK, Medline Kit SKU Number: DYNJ67225C; 14. AFIB TRAY, Medline Kit SKU Number: DYNJ85069; 15. AFIB TRAY, Medline Kit SKU Number: DYNJ85069A; 16. AFIB TRAY, Medline Kit SKU Number: DYNJ85069B; 17. MTO,LEFT HEART,KIT, Medline Kit SKU Number: VASC1811. Namic medical convenience kits, containing Namic Manifold, Labeled as: 1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS,4 VALVE,LFT,HRT,KIT, Medline Kit Number/SKU 60010468; 3. MTO,ADD,ON,KIT, Medline Kit Number/SKU 60010469; 4. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 5. MTS,LFT,HRT,KIT, Medline Kit Number/SKU 60012911; 6. MTO,RIGHT HEART,KIT, Medline Kit Number/SKU 60012912; 7. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60013001; 8. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60013101; 9. MTS,LFT,HRT,W/WIRE, Medline Kit Number/SKU 60013112; 10. MTS,-,3V,KIT, Medline Kit Number/SKU 60020608; 11. MTO,ANGIO,KIT, Medline Kit Number/SKU 60032681; 12. MTS-LEFT HEART,KIT, Medline Kit Number/SKU 60033123; 13. MTS,RIGHT HEART,KIT, Medline Kit Number/SKU 60033124; 14. MTO,LEFT HEART,KIT, Medline Kit Number/SKU 60034644; 15. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60040273; 16. MTO,2V,LEFT HEART,KIT, Medline Kit Number/SKU 60040424; 17. MTS,3,VAVLE,KIT, Medline Kit Number/SKU 60041082; 18. MTS,2V,KIT, Medline Kit Number/SKU 60042453; 19. MTO,3V,KIT, Medline Kit Number/SKU 60042454; 20. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60042721; 21. MTS,3 VALVE,KIT, Medline Kit Number/SKU 60050183; 22. MTS,3 VALVE,MANIFOLD,KIT, Medline Kit Number/SKU 60060268; 23. MTO,RT,HRT,KIT, Medline Kit Number/SKU 60060564; 24. MTO,LEFT HEART,KIT, Medline Kit Number/SKU 60060569; 25. MTS, Medline Kit Number/SKU 60062021; 26. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60071232; 27. MTO,CATH,LAB,KIT, Medline Kit Number/SKU 60080221; 28. MTO,RIGHT, Medline Kit Number/SKU 60080347; 29. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60080349; 30. MTS,MANIFOLD,KIT, Medline Kit Number/SKU 60080716; 31. MTS,LEFT,HRT,KIT, Medline Kit Number/SKU 60081001; 32. MTS,RIGHT HEART,KIT, Medline Kit Number/SKU 60081002; 33. MTO,LEFT,HRT(RT,HANDED), Medline Kit Number/SKU 60081168; 34. MTO,RIGHT HEART,KIT, Medline Kit Number/SKU 60090123; 35. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60091111; 36. MTS,EP,KIT, Medline Kit Number/SKU 60100056; 37. MTS,3 VALVE,LEFT HEART,KIT, Medline Kit Number/SKU 60100338; 38. MTO,RIGHT HEART,KIT, Medline Kit Number/SKU 60100339; 39. DBD-MTO,LEFT HEART,KIT, Medline Kit Number/SKU 60110273; 40. MTO,RIGHT HEART,KIT, Medline Kit Number/SKU 60110701; 41. MTS,3 VALVE,KIT, Medline Kit Number/SKU 60120693; 42. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60121817; 43. MTO,CATH,KIT, Medline Kit Number/SKU 60130124; 44. MTO,LEFT HEART,KIT, Medline Kit Number/SKU 60130318; 45. DBD-MTS,3 VALVE,KIT, Medline Kit Number/SKU 60130506; 46. MTO,RT HEART,KIT, Medline Kit Number/SKU 60131323; 47. MTS,LEFT,HRT,KIT, Medline Kit Number/SKU 60131324; 48. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60131554; 49. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60131815; 50. MTO,RT,HRT,KIT, Medline Kit Number/SKU 60
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·May 20, 2026