17 results · 21ms · Sources: EU EUDAMED, 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