51 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TOUAREG NP CLOSEFIT DENTAL IMPLANTS SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Bernafon
FDA UDI
Bernafon AG·05711584052419·JU7 CIC, BE JUNA 7
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197052887·Crile Hemostatic Forceps
1x2 te...
ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY
FDA 510(k)
FDA Class 2
·Hematology
HISTOACRYL FLEXIBLE PACK 5
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code MPN·December 3, 2019
K-WIRE, RECON 3.2X400 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·June 29, 2011
ADVANCE 18 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·August 24, 2017
ADVANCE 18 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·August 24, 2017
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·October 3, 2014
LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·May 31, 2013
VISX EXCIMER LASER
FDA Adverse Event
Injury
·AMO MANUFACTURING USA, LLC·Product code LZS·June 15, 2011
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
ADVANCE 18 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·May 31, 2017
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
ADVANCE 18 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·March 30, 2017
ADVANCE 18 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·July 27, 2017
ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LIT·November 16, 2016
ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LIT·October 25, 2017
ADVANCE 18 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·November 27, 2018