23 results · 23ms · 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.

MicroPort CoCr Femoral Heads

FDA 510(k)
FDA Class 2 ·Orthopedic

Bernafon

FDA UDI
Bernafon AG·05711584090312·ZERENA 1 MNR FW 3.0

Ophthalmic Retractor

FDA UDI
KATENA PRODUCTS, INC.·00841668101094·HELVESTON "BIG BARBIE" RETRACTOR 9MM

PGA

FDA Adverse Event
Malfunction ·CP MEDICAL·Product code GAM·July 2, 2019

PGA

FDA Adverse Event
Malfunction ·CP MEDICAL·Product code GAM·October 21, 2019

PGA

FDA Adverse Event
Malfunction ·CP MEDICAL·Product code GAM·October 21, 2019

PGA

FDA Adverse Event
Malfunction ·CP MEDICAL·Product code GAM·October 21, 2019

ACUMED WRIST ARTHRODESIS PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

NEONATAL BIOTINIDASE KIT, MODEL 3018

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ROD, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019

5.5 TI CANNULATED TRANSLATION SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019

TOTALCARE BARIATRIC PLUS BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·June 11, 2013

FLOGARD

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

FORCE FX-C GENERATOR

FDA Adverse Event
Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·September 24, 2008

POLARIS SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·January 8, 2020

Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970

FDA Enforcement
Class II ·Ongoing·CP Medical Inc·December 18, 2019

PEDICLE SCREW UNSPECIFIED

FDA Adverse Event
Malfunction ·ZIMMER BIOMET SPINE INC.·Product code NKB·April 20, 2021

PEDICLE SCREW UNSPECIFIED

FDA Adverse Event
Malfunction ·ZIMMER BIOMET SPINE INC.·Product code NKB·April 20, 2021

BD SYRINGE WITH NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·June 17, 2019

BINAXNOW COVID-19 AG SELF TEST 2CT

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·December 19, 2022