20 results · 29ms · 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.

AERO -C Cervical Cage System

FDA 510(k)
FDA Class 2 ·Orthopedic

HairCheck-DT (Cocaine)

FDA UDI
Quest Diagnostics·00868586000216·HairCheck-DT (Cocaine) is an ELISA test kit use...

LEONE SPA

FDA UDI
LEONE SPA·08033707014508·CALIBRA 1ST MOL BANDS W/G8325-02 n.UR 32

Bone Curette

FDA UDI
ELLIQUENCE, LLC·00846338005634·

Endo-Model Knee System - Instruments

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575247899·Orthopaedic implant aiming/guiding block, reusa...

Endo-Model Knee System - Instruments

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575305575·Orthopaedic implant aiming/guiding block, reusa...

Endo-Model Knee System - Instruments

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575247912·Orthopaedic implant aiming/guiding block, reusa...

Signature Femoral Head

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215001872·

Endo-Model Knee System - Instruments

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575247929·Orthopaedic implant aiming/guiding block, reusa...

Endo-Model Knee System - Instruments

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575305568·Orthopaedic implant aiming/guiding block, reusa...

Endo-Model Knee System - Instruments

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575247875·Orthopaedic implant aiming/guiding block, reusa...

Endo-Model Knee System - Instruments

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575247936·Orthopaedic implant aiming/guiding block, reusa...

Endo-Model Knee System - Instruments

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575247882·Orthopaedic implant aiming/guiding block, reusa...

IMAX 9.5 STERILIZERS

FDA 510(k)
FDA Class 2 ·General Hospital

HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING

FDA 510(k)
FDA Class 2 ·Cardiovascular

WAVEWRITER ALPHA 16

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 11, 2025

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

FDA Adverse Event
Malfunction ·MEDTRONIC, INC.·Product code LWP·June 7, 2013

S-ICD SYSTEM

FDA Adverse Event
Injury ·CAMERON HEALTH·Product code LWS·August 11, 2014

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 22, 2011

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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