414 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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