13 results · 23ms · Sources: EU EUDAMED, US FDA

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ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)

FDA 510(k)
FDA Class 2 ·Microbiology

Oticon

FDA UDI
Oticon A/S·05707131340047·SIYA 2, KIT 312 2.4G NFM 90 L C001

PRO-PICC

FDA 510(k)
FDA Class 2 ·General Hospital

SMDIA-1000

FDA 510(k)
FDA Class 2 ·Anesthesiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 22, 2025

M2A-38 CUP NON FLARED SZ 54MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·October 22, 2014

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 27, 2013

ACCU-CHEK ® COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 4, 2011

DLT TS CER HD 12/14 32MM +1

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code HTQ·October 4, 2021

SUP/POST AUG PLATE, R RS GLENOID BASEPLATE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWS·July 18, 2024

ALTRX LIP LNR 32IDX52OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·October 4, 2021

EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·July 18, 2024

Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices.

FDA Enforcement
Class II ·Terminated·Cook Inc.·March 8, 2017