15 results · 26ms · 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.

Lyra Influenza A+B Assay

FDA 510(k)
FDA Class 2 ·Microbiology

Integra® Jarit®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780165491·Integra® Jarit® Stille-Luer Rongeur, 10", 10mm ...

RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENT

FDA 510(k)
FDA Class 2 ·Orthopedic

ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

FDA Adverse Event
Injury ·SYNTHES USA·Product code NKB·October 18, 2016

OT ULTRA2 METER

FDA Adverse Event
Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 8, 2017

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2025

UNKNOWN DEPUY FEMORAL COMPONENT

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HSA·November 12, 2008

PRECISION®

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 1, 2011

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 16, 2013

NEU_INS_STIMULATOR

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·July 23, 2012

UNKNOWN

FDA Adverse Event
Injury ·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MIH·October 31, 2022

UNKNOWN

FDA Adverse Event
Injury ·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MIH·October 31, 2022

Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin and either an 18-gauge or a 19-gauge 5 micron filter needle. Ref: IVT-KIT-29G

FDA Enforcement
Class II ·Ongoing·Apellis Pharmaceuticals, Inc.·October 11, 2023

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025