22 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AMEDICA DRUG SCREEN PHENCYCLIDINE TEST
FDA 510(k)
FDA Unclassified
·Unknown
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113844·VISCO CANNULA 21GA ANGLE 8MM
True Position®
FDA UDI
ATLAS SPINE, INC.·M68112080231090·31mm x 9mm Non-Lordotic Spacer
COMPLETE BRAND LUBRICATING AND REWETTING DROPS
FDA 510(k)
FDA Class 2
·Ophthalmic
SONOPSY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACUITY CENTRAL MONITORING
FDA Adverse Event
Malfunction
·WELCH ALLYN PROTOCOL, INC.·Product code DSI·February 27, 2013
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·February 15, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 3, 2008
HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
PIPELINE
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·September 13, 2023
PIPELINE
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·September 13, 2023
PIPELINE
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·September 13, 2023
UNKNOWN EEA
FDA Adverse Event
Injury
·US SURGICAL PUERTO RICO·Product code GDW·December 14, 2023
UNKNOWN EEA
FDA Adverse Event
Injury
·US SURGICAL PUERTO RICO·Product code GDW·December 14, 2023
UNKNOWN EEA
FDA Adverse Event
Death
·US SURGICAL PUERTO RICO·Product code GDW·December 15, 2023
ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code OAE·August 2, 2023
MEDTRONIC ICD
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code DXY·December 20, 2023
NOVOTWIST 8 MM (30G)
FDA Adverse Event
Injury
·NOVO NORDISK A/S, MS HJOERRING·Product code FMI·August 11, 2016
MEDTRONIC
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code DXY·December 20, 2023
Accolade TMZF Plus Hip Stem: Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5 Catalog #6020-3535 Accolade 132 Size 3.5 Catalog # 6021-0230 Accolade Plus TMZF Hip Stem #2 Catalog # 6021-0335 Accolade Plus TMZF Hip Stem #3 Catalog #3021-0435 Accolade TMZF Hip Stem #4 Catalog # 6021-0435 Accolade Plus TMZF Hip Stem #4 Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5 Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 K994366; k023105; K032300 Manufactured by " Stryker Ireland, Carrigtwohill Industrial Estate Carrington County Cork, Ireland The subject hip stem is a single-use device intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code ISL·March 1, 2011