17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526189805·LEVAMED ACTIVE ANKLE SUP BLACK R V
OptumSI Implant System
FDA UDI
SI Solutions, LLC·00850057247183·Sacroiliac Joint Fusion Implant, 11.5mm x 35mm
Exact Medical Manufacturing, Inc.
FDA UDI
EXACT MEDICAL MANUFACTURING, INC.·00850031271906·Drill Cover, Cardboard Insert, Perf. Tip 8.5x50...
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213020504·Coupling Treatment Tubes Set for Metal Needles ...
SurgyCut
FDA UDI
U.S. SURGITECH INC.·00810014631318·SurgyCut L - Wire with Suction & Electrode, 5mm...
BT-CATH
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CADENCE PRECISION INJECTOR, MODEL 103-0304
FDA 510(k)
FDA Class 2
·Cardiovascular
V60 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC·Product code MNT·March 7, 2019
DRIVER; SIZE 10
FDA Adverse Event
Malfunction
·K2M, INC.·Product code LXH·July 12, 2022
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code PAH·May 14, 2013
CORAIL AMT COLLAR SIZE 11
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code LWJ·May 13, 2011
PROSTAR XL SUTURE-MEDIATED CLOSURE
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·August 13, 2008
EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·February 19, 2026
Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022
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