17 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.

Intense Pulsed Light Treatment System (LK-PT)

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

Blade Scalpel

FDA UDI
KATENA PRODUCTS, INC.·00841668113448·SUPER SHARPS 15 DEG 3MM (BX/5)

Evolve Masters

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215002343·

Evolve Stem

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215051990·

EXPERIENCE®

FDA UDI
Gc Orthodontics America Inc.·D78824244000201·EXRC MBT 022/LR4 -12T 2A

Infrared Thermometer

FDA 510(k)
FDA Class 2 ·General Hospital

ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

RELION INSULIN SYRINGE 3/10ML 29G X 8MM

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·March 22, 2022

ENDURANT II

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·June 27, 2014

ENDURANT II

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·June 27, 2014

ALARIS SYSTEM

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

ENDURANT II

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code MIH·June 27, 2014

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·November 11, 2014

DURATA STS OPTIM ACTIVE FIXATION

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·July 23, 2013

ANEURX

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·June 14, 2013

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