45 results · 27ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

DOPPLER MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

LISTER BANDAGE SCISSORS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896075467·LISTER BANDAGE SCISSORS POWER CUT GOLD

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306837197·Talei Necklift Retractor Narrow, "Le Petit Bene...

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306837180·Talei Necklift Retractor XL, "Benetrator Magnum...

K140347

FDA Adverse Event
Injury ·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 6, 2021

K140347

FDA Adverse Event
Injury ·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 6, 2021

LATEX EXAMINATION GLOVES-POWDERED, NONSTERILE

FDA 510(k)
FDA Class 1 ·General Hospital

OPTIBOND SE

FDA 510(k)
FDA Class 2 ·Dental

OT VERIO2 METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 17, 2017

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 7, 2025

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 23, 2014

X8000 LIGHTSOURCE

FDA Adverse Event
Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·April 25, 2011

SPECIFIC DEVICE NOT REPORTED

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·October 22, 2024

LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 13MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·April 13, 2023

SPECIFIC DEVICE NOT REPORTED

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·December 17, 2024

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

LOGIC FEMORAL PS CEM LEFT SZ 3.5

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·March 5, 2025

LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·June 30, 2022

LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·September 5, 2024