17 results
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26ms
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Sources: EU EUDAMED, US FDA
TORX OR TYPE MICRO MOTOR HANDPIECE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Total Foot System 2
FDA UDI
Smith & Nephew, Inc.·00885556838631·2.2MM PLATE LOCKING SCREW 8MM
Integra® Total Foot System
FDA UDI
Ascension Orthopedics, Inc.·10381780119029·The locking forefoot screw is used in the Integ...
Tranquil-L™
FDA UDI
NEXUS SPINE, L.L.C.·B6788220080·8mm Left Handed Nerve Root Retractor
NTI
FDA UDI
NTI - Kahla GmbH Rotary Dental Instruments·E310822008MFG1·NTI Diamond Medium FG
NTI
FDA UDI
NTI - Kahla GmbH Rotary Dental Instruments·E310822008CFG1·NTI Diamond Coarse FG
VQ ORTHOCARE
FDA UDI
Vision Quest Industries Incorporated·00817717020494·OACTIVE2 OTS Standard RIGHT
VQ ORTHOCARE
FDA UDI
Vision Quest Industries Incorporated·00817717020500·OACTIVE2 OTS Heavy Duty RIGHT
CARDIMA ABLATION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 20, 2014
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·October 1, 2012
SENSIA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NVZ·September 1, 2010
OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370
FDA Enforcement
Class II
·Ongoing·Osteomed, LLC·December 15, 2021
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012