18 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE
FDA 510(k)
FDA Class 2
·Dental
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902003530·CROSSLINK 8110615 CDH ANT PLT 15MM TI
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK110151·DD tempMED are pre-colored dental milling blank...
ASP
FDA UDI
SEDATELEC·03760262490441·The ASP Original, Semi-Permanent Needle, is an ...
INTREPED, Intraosseous Fusion Device
FDA UDI
Auxano Medical LLC·00850055649019·INTREPED 06x15 implant
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0106150·Trial, 26 x 15mm, 8 Degree, Tapered, Straight
Leva® Anterior Interbody System
FDA UDI
Spine Wave, Inc.·10840642112474·Modular Spacer, 26 mm (W) x 26 mm (L) x 17 mm (...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306803123·Weitlaner Retractor, 3x4 Prong, Blunt, 16.5cm
ARSTASIS ACCESS SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
CYCLOTEC AMT CTI TENS DEVICE
FDA 510(k)
FDA Class 2
·Neurology
BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·December 21, 2022
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 10, 2013
HOMECHOICE PRO
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·September 23, 2014
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·June 1, 2011
ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·May 21, 2012
Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·August 30, 2017
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024