414 results · 24ms · Sources: EU EUDAMED, US FDA

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Adhesive Electrodes

FDA 510(k)
FDA Class 2 ·Neurology

N/A

FDA UDI
GEORGE TIEMANN & CO.·B5821601380·SCISSORS, SURGICAL TISSUE, DENTAL

RESTORIS

FDA UDI
MAKO SURGICAL CORP.·00848486020156·Tibial Baseplate Template Std RM/LL Sz8

LeMaitre Embolectomy Catheter

FDA UDI
Lemaitre Vascular, Inc.·00840663100583·3F 80 cm LeMaitre Embolectomy Catheter, eIFU

LeMaitre Embolectomy Catheter

FDA UDI
Lemaitre Vascular, Inc.·00840663100477·3F 80 cm LeMaitre Embolectomy Catheter

LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi.

FDA Enforcement
Class II ·Terminated·LeMaitre Vascular, Inc.·December 16, 2015

LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi.

FDA Recall
Terminated ·LeMaitre Vascular, Inc.·Product code DXE·October 21, 2015

SMOOTH K-WIRE, DOUBLE END BAYONET POINT

FDA UDI
Biomet Orthopedics, LLC·00887868016240·

ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

SM304 M-SERIES W/ZOOM

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code INK·June 10, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011

530G INSULIN PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OZO·September 19, 2014

ONE TOUCH PROFILE

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·March 22, 2002

BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·September 17, 2025

BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·September 19, 2025

BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code NJR·April 17, 2026

BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·May 20, 2026

BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·May 14, 2026

BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·May 20, 2026