16 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SOLITAIRE FR REVASCULARIZATION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169605466·SPACER 2113455 OLIF25 20MM 18 DEG 14X55
CapSure® Spine System
FDA UDI
Spine Wave, Inc.·10840642104783·PS2 Screw 4.5mm x 55mm
KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPECTRA LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·March 11, 2022
UNKNOWN DEPUY TRI-LOCK FEMORAL HIP STEM
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWY·May 15, 2013
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014
UNKNOWN ZIMMER KNEE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·May 31, 2011
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·August 17, 2023
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·April 8, 2025
TI-SU03 GC
FDA Adverse Event
Injury
·NAKANISHI INC. (NSK)·Product code EFB·May 26, 2015
COBAS AMPLIPREP / COBAS TAQMAN 48 ANALYZER
FDA Adverse Event
Malfunction
·ROCHE DIAGNSOTICS, LTD.·Product code JJF·October 4, 2010
SOLO
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code HMX·August 24, 2021
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
ACCOLADE DR EL MRI (Model L331)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025