13 results · 21ms · Sources: EU EUDAMED, US FDA

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Phantom Metatarsal Shortening System

FDA 510(k)
FDA Class 2 ·Orthopedic

ASO Ankle Stabilizer

FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357231843·

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114100·SIMCOE CORTEX EXTRACTOR 21GA 0.4MM PK/10

FINN CHAMBERS AQUA

FDA 510(k)
FDA Class 1 ·General Hospital

ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

CADD

FDA Adverse Event
Malfunction ·ST PAUL·Product code FRN·April 28, 2022

1823260-2017-02035

FDA Adverse Event
Malfunction ·September 21, 2017

DURATA STS OPTIM ACTIVE FIXATION

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008

ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KNT·August 25, 2011

OBTRYX SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 12, 2013

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

FDA Enforcement
Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

FDA Enforcement
Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

Model Number L111, ESSENTIO DR SL MRI Pacemaker

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