13 results · 21ms · 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.

HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50

FDA 510(k)
FDA Class 2 ·Microbiology

AGC V2 TOTAL KNEE SYSTEM

FDA UDI
Biomet Orthopedics, LLC·05019279383801·

APPLIANCE, FIXATION, SPINAL INTERLAMINAL

FDA Adverse Event
Injury ·SYNTHES USA·Product code KWP·March 31, 2016

Endo-Model Modular Knee Prosthesis System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575316618·Hinge Knee Joint Prosthesis,with anti-luxation ...

LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4

FDA 510(k)
FDA Class 2 ·Hematology

PATIENT EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

TILOCK PEDICLE SCREW SYSTEM

FDA Adverse Event
Other ·GENESYS SPINE·Product code NKB·July 2, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

PROTECTA XT VR

FDA Adverse Event
Malfunction ·IPG MFG SWITZERLAND·Product code LWS·June 8, 2013

ANTI ROTATION LAG SCREW

FDA Adverse Event
Injury ·DEPUY ACE S.A. 'R.L.·Product code HWC·September 5, 2008

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

ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023