14 results · 24ms · Sources: EU EUDAMED, US FDA

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V30 system, V-Form Handpiece BC Medium applicator

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

Bi-Metric® Revision Hip System

FDA UDI
Biomet Orthopedics, LLC·00887868261527·

BI-METRIC REVISION HIP SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304003514·

BI-METRIC(R) HEAD/NECK PROVISIONAL

FDA UDI
Biomet Orthopedics, LLC·00880304307551·

COTTLE NASAL SPECULUM

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896090422·COTTLE NASAL SPECULUM MODIFIED THIN WIDE BLADES

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 13, 2021

BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM

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

SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004

FDA 510(k)
FDA Class 2 ·General Hospital

BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·April 25, 2022

PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

FDA Adverse Event
Malfunction ·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·June 6, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011

ONE TOUCH ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code NBW·September 9, 2008

BD PHOENIX¿ NMIC-306

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·December 10, 2024

OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021