11 results · 25ms · 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.

MANAN UBK ULTRASONIC GUIDED BIOPSY KIT

FDA 510(k)
FDA Class 1 ·Gastroenterology, Urology

Shoreline ACS

FDA UDI
Seaspine Orthopedics Corporation·10889981125066·5mm, Locking Cover

Endo-Model Modular Knee Prosthesis System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575383207·Rotational Knee Joint Prosthesis,with anti-luxa...

Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

WATER FILLED TEETHER

FDA 510(k)
FDA Class 2 ·Dental

ACCU-CHEK SPIRIT COMBO

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·November 14, 2012

CRE? WIREGUIDED

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - CORK·Product code FGE·June 5, 2014

SYNCHROMED EL

FDA Adverse Event
Malfunction ·RICE CREEK MFG·Product code LKK·September 28, 2010

Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-2817/11, 15-2817/12, 15-2818/11, 15-2818/12, 15-2834/01, 15-2834/02, 15-2834/03, 15-2834/04, 15-2835/11, 15-2835/12, 15-2836/11, 15-2836/12, 15-2837/11, 15-2837/12, 15-2838/11, 15-2838/12, 15-3815/11, 15-3815/12, 15-3816/11, 15-3816/12, 15-3817/11, 15-3817/12, 15-3818/11, 15-3818/12, 15-8521/05, 15-8521/07, 15-8521/09, 15-8521/11, 15-8521/15, 15-8521/25, 15-8521/27, 15-8521/29, 15-8521/31, 15-8521/33

FDA Enforcement
Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·July 24, 2024

Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-2817/11, 15-2817/12, 15-2818/11, 15-2818/12, 15-2834/01, 15-2834/02, 15-2834/03, 15-2834/04, 15-2835/11, 15-2835/12, 15-2836/11, 15-2836/12, 15-2837/11, 15-2837/12, 15-2838/11, 15-2838/12, 15-3815/11, 15-3815/12, 15-3816/11, 15-3816/12, 15-3817/11, 15-3817/12, 15-3818/11, 15-3818/12, 15-8521/05, 15-8521/07, 15-8521/09, 15-8521/11, 15-8521/15, 15-8521/25, 15-8521/27, 15-8521/29, 15-8521/31, 15-8521/33

FDA Recall
Open, Classified ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JWH·May 22, 2024

Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

FDA Enforcement
Class II ·Terminated·STERILMED, INC.·December 16, 2015