14 results · 23ms · 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.

LATERAL Spine Truss System

FDA 510(k)
FDA Class 2 ·Orthopedic

ELMED

FDA UDI
ELMED INCORPORATED·00842180156593·Metz. Scissors Double Action, Cystoscopy Fleibl...

ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE

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

530G INSULIN PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 8, 2014

TARGET TIP

FDA Adverse Event
Malfunction ·MPRI·Product code DTB·June 8, 2013

RESTORE ULTRA

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·June 21, 2011

FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

FDA Adverse Event
Injury ·COOK INC·Product code DYB·October 29, 2025

FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

FDA Adverse Event
Injury ·COOK INC·Product code DYB·October 29, 2025

DYB INTRODUCER, CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code DYB·November 12, 2025

FLEXOR SHUTTLE SELECT GUIDING SHEATH

FDA Adverse Event
Injury ·COOK INC·Product code DYB·October 29, 2025

UNKNOWN

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·September 15, 2020

FLEXOR SHUTTLE SELECT GUIDING SHEATH

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·February 7, 2020

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