14 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MAGLIFE C/MAGLIFE C PLUS
FDA 510(k)
FDA Class 2
·Cardiovascular
GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC
FDA 510(k)
FDA Class 2
·General Hospital
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES
FDA 510(k)
FDA Class 2
·Microbiology
AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code NGV·July 24, 2023
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 27, 2013
ARCTIC FRONT CARDIAC CRYOABLATION CATHETER
FDA Adverse Event
Death
·MEDTRONIC CRYOCATH LP·Product code OAE·March 16, 2011
HINGED TOE IMPLANT
FDA Adverse Event
Other
·WRIGHT MEDICAL·Product code KWD·March 24, 2008
Angled Tip Ureteral Catheter Set, Ureteral Catheter, Global Product No. G14598
FDA Enforcement
Class II
·Terminated·Cook Inc.·February 12, 2020
AMPLATZER AMULET
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code NGV·September 6, 2023
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 24, 2025
ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·August 7, 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
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012