28 results · 25ms · Sources: EU EUDAMED, US FDA

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MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS

FDA 510(k)
FDA Class 2 ·Dental

N/A

FDA UDI
BIOMET MICROFIXATION, INC·00841036028213·

CT/MR Ring & Tandem Set, 26mm, 60ø, Varian

FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330022554·

SYNCARDIA 70CC TAH-T

FDA Adverse Event
Malfunction ·SYNCARDIA SYSTEMS, LLC·Product code LOZ·August 1, 2016

CT/MR R&T Ring Tube, 60ø, 26mm ring only, Varian

FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330022561·

HANSATOME MICROKERATOME

FDA 510(k)
FDA Class 1 ·Ophthalmic

GELBFISH FLEX VASCULAR DILATOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

VELYS ARRAY SET KNEE

FDA Adverse Event
Malfunction ·DEPUY IRELAND - 3015516266·Product code OLO·August 13, 2024

ATTUNE CR FEM TRIAL SZ 7 RT

FDA Adverse Event
Malfunction ·DEPUY IRELAND - 9616671·Product code HWT·September 24, 2025

ATTUNE SHIMS & GEN INST

FDA Adverse Event
Malfunction ·DEPUY IRELAND - 3015516266·Product code FSM·January 27, 2026

HEARTSTART MRX

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 19, 2013

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·September 15, 2014

REALIZE ADJ GASTRIC BAND-C

FDA Adverse Event
Malfunction ·OBTECH MEDICAL SARL_·Product code LTI·May 16, 2011

XP-CR Tibial Tray - Interlok 83 mm Item # 195277

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

BASEPLATE INSERTER ROD

FDA Adverse Event
Malfunction ·DEPUY IRELAND - 3015516266·Product code LXH·January 16, 2025

BASEPLATE INSERTER ROD

FDA Adverse Event
Malfunction ·DEPUY IRELAND - 3015516266·Product code LXH·August 26, 2024

VELYS SAW BLADE

FDA Adverse Event
Injury ·DEPUY IRELAND - 9616671·Product code OLO·November 18, 2025

DPS AL CASE FULL MID HEIGHT

FDA Adverse Event
Malfunction ·DEPUY IRELAND - 3015516266·Product code FSM·September 2, 2025

BASEPLATE INSERTER ROD

FDA Adverse Event
Malfunction ·DEPUY IRELAND - 3015516266·Product code LXH·December 19, 2024

ATTUNE CR FEM TRIAL SZ 6 RT

FDA Adverse Event
Malfunction ·DEPUY IRELAND - 9616671·Product code HWT·February 26, 2026