128 results · 28ms · 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.

LIGHT BOND (QUICK CURE)

FDA 510(k)
FDA Class 2 ·Dental

artVeneer life

FDA UDI
Merz Dental GmbH·D7092001048·artVeneer life upper anteriors, IM, A2

TheraFlo M-set 42'' × 84'' QLT Recover

FDA UDI
Tridien Medical·00841965103784·TheraFlo M-set 42'' × 84'' QLT Recover

JBC

FDA UDI
FOREMOUNT ENTERPRISE CO., LTD.·04719871892275·Tracheal HME

TruFlex™

FDA UDI
Ortho Organizers, Inc.·00190707126827·TRUFLEX NiTi Thermal Upper 19x25 (10pk)

TruFlex

FDA UDI
ORTHO TECHNOLOGY, INC.·00190730015075·NiTi Thermal Upper 19x25 10 archwires per pack

TheraFlo Cover 54'' × 80'' QLT Sen-1p

FDA UDI
Tridien Medical·00841965103937·TheraFlo Cover 54'' × 80'' QLT Sen-1p

Medical Facets NC

FDA UDI
MEDICAL FACETS NC LLC·M933MDF20010480·2.4mm Cannulated Screw, Self Drilling, Short Th...

SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1

FDA 510(k)
FDA Class 2 ·General Hospital

RGP MULTI-PURPOSE SOLUTION ID 100136

FDA 510(k)
FDA Class 2 ·Ophthalmic

DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code PQF·January 31, 2018

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 13, 2013

UNKNOWN ZIMMER MIS TIBIAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER INC·Product code JWH·February 21, 2011

PULSE GEN MODEL 102

FDA Adverse Event
Injury ·CYBERONICS, INC.·Product code LYJ·February 22, 2008

BIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar Bipolar Cup is indicated in: Total hip replacement

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

LUMIRADX SARS-COV-2 AG TEST STRIP KIT

FDA Adverse Event
Malfunction ·LUMIRADX UK LTD·Product code QKP·April 28, 2023

LUMIRADX SARS-COV-2 AG TEST STRIP KIT

FDA Adverse Event
Malfunction ·LUMIRADX UK LTD·Product code QKP·April 28, 2023

LUMIRADX SARS-COV-2 AG TEST STRIP KIT

FDA Adverse Event
Malfunction ·LUMIRADX UK LTD·Product code QKP·April 28, 2023

LUMIRADX SARS-COV-2 AG TEST STRIP KIT

FDA Adverse Event
Malfunction ·LUMIRADX UK LTD·Product code QKP·April 28, 2023

LUMIRADX SARS-COV-2 AG TEST STRIP KIT

FDA Adverse Event
Malfunction ·LUMIRADX UK LTD·Product code QKP·April 28, 2023