25 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741324300·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674132430060·
RC Screw-retained Abutment
FDA UDI
BIO CONCEPT Co., Ltd.·06947600303305·
AGXO
FDA UDI
Oticon A/S·05707131257178·H160, BTE 13 WL 85 CNB AGXO
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668103012·LIPPMAN SIDEPORT NUCLEUS SPATULA
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837000509·
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837000516·
ACUEITY MEDICAL LIGHT SOURCE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET
FDA 510(k)
FDA Class 2
·Cardiovascular
LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·August 8, 2016
LIFEPAK(R) 1000 DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·July 10, 2015
LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·December 23, 2014
ASPHERE M SPEC 12/14 36 +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code JDI·May 29, 2013
PROXIMATE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GDW·June 16, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 22, 2008
UNKNOWN KNEE TIBIAL INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·October 9, 2019
UNKNOWN KNEE TIBIAL TRAY
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·October 18, 2019
UNKNOWN KNEE FEMORAL
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·October 18, 2019
THERMAGE CPT SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code GEI·November 12, 2020