19 results · 24ms · 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.

RESCAN

FDA 510(k)
FDA Class 2 ·Anesthesiology

Maxim® Knee System

FDA UDI
Biomet Orthopedics, LLC·00887868225161·

MAXIM KNEE SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304011182·

Bright Tray

FDA UDI
ORMCO CORPORATION·00889989059793·BRIGHT TRAY-LOWER-SIZE 16-GREEN-PK 20

N/A

FDA UDI
BIOMET MICROFIXATION, INC·00841036031664·

Merit® Kit

FDA UDI
Merit Medical Systems, Inc.·00884450256398·

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K1100540·Caddie, 8.5mm Screws

Surgical Direct

FDA UDI
Surgical Direct, Inc.·B382SD221081400540·10 3/4" Malis Bayonet Bipolar Forceps with Irri...

Surgical Direct

FDA UDI
Surgical Direct, Inc.·B382SD220881400540·8 3/4" Malis Bayonet Bipolar Forceps with Irrig...

NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE

FDA 510(k)
FDA Class 2 ·Neurology

BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE

FDA 510(k)
FDA Class 1 ·General Hospital

MAX PRI TIB BRNG 14X79/83

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 1, 2019

OPTISENSE

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·January 13, 2014

OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

FDA Adverse Event
Malfunction ·Product code FJI·May 29, 2013

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·June 25, 2011

MAXIM PRIMARY TIBIAL BEARING 10MM THICK X 79/83 MM WIDE

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·March 2, 2017

RELION INSULIN SYRINGES 1/2ML 31 GAUGE, 8MM (5/16") U-100 100COUNT

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·July 15, 2022

Philips DuraDiagnost stationary X-ray system

FDA Enforcement
Class II ·Terminated·Philips Electronics North America Corporation·September 7, 2016

Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013