13 results · 29ms · 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.

RFVISION, MODEL 9.9D

FDA 510(k)
FDA Class 2 ·Radiology

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014607849·STERIS-AMSCO 3080, 3085 3" STANDARD

WAVEWRITER ALPHA 16

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 1, 2023

K'FIX

FDA 510(k)
FDA Class 2 ·Orthopedic

ORALUBE

FDA 510(k)
FDA Class 1 ·Dental

LINEAR ST

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 16, 2020

BD LUER-LOK¿ SYRINGE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·September 21, 2018

HEARTSTART XL

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·August 25, 2014

CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING

FDA Adverse Event
Death ·EDWARDS LIFESCIENCES·Product code KRH·May 6, 2011

MENTOR

FDA Adverse Event
Injury ·Product code FWM·July 22, 2008

BD LUER-LOK¿ SYRINGE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·June 12, 2018

GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments

FDA Enforcement
Class II ·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016

Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024