24 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Zaontz
FDA UDI
COOK INCORPORATED·00827002150508·Zaontz Urethral Stent
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120323101·Diamond, flame, COOL DIAMANT, fine grit, red ring
DELFIA Neonatal hTSH kit
FDA UDI
Wallac Oy·06438147140466·Time-resolved fluoroimmunoassay for the quantit...
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102374·BARRAQUER IRIS SPATULA 0.25MM
CARDIOBEEPER CB12/12, MODEL CB12/12
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·February 21, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 30, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·January 16, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·January 6, 2011
AVALUS AORTIC TISSUE VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·June 23, 2020
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 29, 2013
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·March 23, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·April 21, 2008
ACCUVUE ADVANCE
FDA Adverse Event
Injury
·VISTAKON·Product code LPL·October 19, 2007
TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01
FDA Enforcement
Class II
·Terminated·ArthroCare Corporation·April 13, 2016
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
I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibula Plate 3.5mm; Article Numbers: 21225-4, 21225-6, 21225-8, 21225-10, 21225-12, 21226-4, 21226-6, 21226-8, 21226-10, 21226-12. 3. Universal Tubular Plate; Article Numbers: 21601-5, 21601-6, 21601-7, 21601-8, 21601-10, 21601-12, 21601-14, 21601-16.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016