15 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DEXTEX II STERILIZATION WRAP
FDA 510(k)
FDA Class 2
·General Hospital
THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope
FDA UDI
THD SPA·08033737710586·The THD Light-Scope rectoscope is a disposable ...
Convaid
FDA UDI
CONVAID PRODUCTS, INC.·10840117400822·
Convaid
FDA UDI
CONVAID PRODUCTS, INC.·00840117408432·
0800,APS1,08,N,LT,VL,JR
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828152846·0800,APS1,08,N,LT,VL,JR
Opaque
FDA UDI
Kerr Corporation·00841396107993·Resin Based Dental Restorative Material - D2
ACUMED
FDA UDI
Acumed LLC·10806378040061·Uni. Tray General Instrument Platter
ADP,1,P800,(2)S800,RESPONDER 3000,3,4
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828118590·ADP,1,P800,(2)S800,RESPONDER 3000,3,4
SPECTRUM
FDA UDI
Ortho Arch Company Inc·D9098001231·SPECTRUM UTILITY ARCH PLIER
APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACUMED WRIST ARTHRODESIS PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
COREVALVE 31MM AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 8, 2014
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·October 17, 2012
BIOINTRAFIX SCREW
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code MBI·August 10, 2010
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021