19 results · 32ms · Sources: EU EUDAMED, US FDA

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AMCOM COMMTECH MESSENGER

FDA 510(k)
FDA Class 2 ·Cardiovascular

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613017705·K-Wire, Double Ended, Trocar Point, Diameter Si...

BioCare Safety Needles

FDA UDI
BIOTRONIX HEALTHCARE INDUSTRIES, INC.·00858835007776·Disposable BioGuard Safety Needles 23G x 1 1/2"

Marker Pin Smooth

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215068615·

CASPIAN Spinal System

FDA UDI
VB Spine LLC·10888857242234·Tapered Double Ended Driver Size 15

3I CALCIUM SULFATE BONE CEMENT

FDA 510(k)
FDA Class 2 ·Dental

LCI OPTION FOR INNOCOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

RIVA STAR SILVER DIAMINE FLUORIDE

FDA Adverse Event
Injury ·SDI LIMITED·Product code LBH·February 13, 2019

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·May 19, 2022

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·April 1, 2022

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·January 16, 2023

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·March 1, 2023

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 7, 2022

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 14, 2013

HEARTMATE II LVAS

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·June 2, 2011

VANTEX CENTRAL VENOUS CATHETHER WITH OLIGON MATERIAL WITH OR

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES, PR·Product code FOZ·August 4, 2008

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·June 14, 2022

cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021