20 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.

HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS)

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814190·GENUMEDI PT SILVER L II

CoRoent

FDA UDI
Nuvasive, Inc.·00887517637482·CoRoent Ant TLIF PEEK, 14x12x28mm 12°

THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES

FDA 510(k)
FDA Class 2 ·Orthopedic

UNISILK

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

BD MAX¿ GROUP B STREPTOCOCCUS

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·December 16, 2025

BD MAX¿ GROUP B STREPTOCOCCUS

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·December 16, 2025

BD MAX¿ GROUP B STREPTOCOCCUS

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·December 16, 2025

BD MAX¿ GROUP B STREPTOCOCCUS

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·December 16, 2025

BD MAX¿ GROUP B STREPTOCOCCUS

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·December 16, 2025

BD MAX¿ GROUP B STREPTOCOCCUS

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·December 16, 2025

BD MAX¿ GROUP B STREPTOCOCCUS

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·December 16, 2025

BD MAX¿ GROUP B STREPTOCOCCUS

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·December 16, 2025

530G INSULIN PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 5, 2014

MAQUET SAS

FDA Adverse Event
Malfunction ·MAQUET S.A.·Product code FSY·May 21, 2013

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 28, 2011

IMP,TSV,4.1MM,DUAL SEL,HA

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·February 5, 2024

IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·February 5, 2024

BD MAX¿ GBS

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·October 15, 2025

R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MMDX44CM, 13MMDX46CM LG, 13MMDX48CM LG, 14MMDX34CM, 14MMDX36CM, 14MMDX38CM, 14MMDX40CM, 14MMDX42CM, 14MMDX44CM, 14MMDX46CM LG, 14MMDX48CM LG

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017