16 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Prosplints
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357130344·
Comprehensive® Shoulder System
FDA UDI
Biomet Orthopedics, LLC·00880304212213·
8950 MASK
FDA UDI
HANS RUDOLPH, INC.·00817136020655·8950 PED LG MASK W/2600 2W
Comprehensive Shoulder System
FDA UDI
Biomet Orthopedics, LLC·00880304681040·
MODIFICATION TO: THERMACOOL IIA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GENESYS SPINE INTERBODY FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
30327 12CC 100 UNIT HEP SYR {CAN} (5CC)
FDA Adverse Event
Malfunction
·COVIDIEN·Product code NZW·April 15, 2010
ARTERIAL CANNULA 20G/45MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·November 15, 2020
U BY KOTEX SLEEK
FDA Adverse Event
Malfunction
·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·August 31, 2018
ELITE 17CM STRAIGHT ATTACHMENT
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBE·September 30, 2015
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 24, 2014
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code HCG·June 3, 2011
U BY KOTEX SLEEK
FDA Adverse Event
Malfunction
·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·June 27, 2018
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·December 18, 2013
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021