16 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VELOPEX AQUACUT FLUID ABRASION UNIT
FDA 510(k)
FDA Class 2
·Dental
APC™ PLUS Victory Series™ Low Profile
FDA UDI
3M UNITEK CORPORATION·00652221094698·Victory Series(TM) Low Profile Bracket APC(TM) ...
APC™ Flash-Free Victory Series™ Low Profile
FDA UDI
3M UNITEK CORPORATION·00652221232267·Victory Series(TM) Low Profile Bracket APC(TM) ...
Humeris Shoulder
FDA UDI
FX SOLUTIONS·03701037304259·TRIAL CENTERED SPACER Ø41 +5 mm 0°
HEARTMATE 3 LVAS IMPLANT KIT
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·July 7, 2021
FORTAFLEX SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPECTRAL'S TROPONIN I
FDA 510(k)
FDA Class 2
·Clinical Chemistry
UNK MAMMARY IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·April 18, 2024
JOSTENT GRAFTMASTER
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MAF·March 27, 2013
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NEK·March 18, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 5, 2008
ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
FDA Adverse Event
Injury
·COOK INC·Product code MIH·October 22, 2024
PANEL PHOENIX NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·December 22, 2023
Portex ULTRA-FLO 4 Way Stopcock Catalog Number: T1210
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code FMG·September 9, 2004
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