16 results · 27ms · Sources: EU EUDAMED, US FDA

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DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System

FDA 510(k)
FDA Class 2 ·Radiology

Vanguard® Knee System

FDA UDI
Biomet Orthopedics, LLC·00880304272019·

Vanguard Knee System

FDA UDI
Biomet Orthopedics, LLC·00880304465664·

COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL

FDA 510(k)
FDA Unclassified ·Unknown

LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

CART 9733856 S7 STAFF ASSEMBLED 110V

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 18, 2019

CART 9733856 S7 STAFF ASSEMBLED 110V

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 6, 2019

STEALTHSTATION S7 SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·February 12, 2018

CART 9734056 S7 STAFF SHRT 100-120V INTL

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 18, 2019

STEALTHSTATION® S7

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·March 18, 2019

COLLEAGUE CX VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008

M2A 38MM MODULAR HEAD STD NK

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 22, 2013

COULTER LH 750 HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·July 8, 2011

I-STAT CHEM8+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JPI·December 17, 2024

SYRINGE 10ML LL S/C 200

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 23, 2019

various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·April 26, 2017