25 results · 22ms · 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.

SPM-300

FDA 510(k)
FDA Class 2 ·Anesthesiology

CoRoent

FDA UDI
Nuvasive, Inc.·00887517636881·CoRoent Ant TLIF PEEK, 13x10x32mm 12°

ArgenZ HT+ 98x14 ML C2B

FDA UDI
ARGEN CORPORATION, THE·D818130322·Dental porcelain/ceramic restoration kit

NUPRO®

FDA UDI
Dentsply Professional·D0031303221·NUPRO® 5% Sodium Fluoride White Varnish, Patien...

N/A

FDA UDI
Tyber Medical, LLC·M695M1303220·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450435434·

Drive

FDA UDI
Drive Devilbiss Healthcare·50822383110115·Stool Seat w/Sq.Gray Cush,2/cs

Portex

FDA UDI
ICU MEDICAL, INC.·15019517075359·

BINAX NOW COVID-19 AG CARD

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·November 10, 2021

EVERCROSS 0.035 OTW PTA DILATION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BINAXNOW COVID-19 AG CARD

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 20, 2021

CONMED ELECTROSURGICAL PENCIL WITH ARGON BEAM COAGULATION

FDA Adverse Event
Malfunction ·CONMED/ASPEN LABS·Product code GEI·September 19, 2000

CONMED ELECTROSURGICAL PENCIL WITH ARGON BEAM COAGULATION

FDA Adverse Event
Malfunction ·CONMED/ASPEN LABS·Product code GEI·September 19, 2000

CATHETER MOUNT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZO·November 25, 2015

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 28, 2025

VENTED HUMIDIFICATION CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 22, 2014

LIKORALL

FDA Adverse Event
Malfunction ·LIKO AB·Product code FSA·March 25, 2013

INFUSOR

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 30, 2014

AFFINITY 3

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code HDD·May 9, 2011