16 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00888233025171·
ALLOGENIX
FDA UDI
BIOMET MICROFIXATION, INC·00841036125851·
MICROCHOICE
FDA UDI
Conmed Corporation·10845854006665·MICROCHOICE OSCILLATOR INTRA-ORAL BLADE 5 X 12 ...
ADAPTOR,1,P103 TO (2)1/4" N
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828119054·ADAPTOR,1,P103 TO (2)1/4" N
PARE ENDOSCOPIC SUTURING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 3, 2008
CLOSUREFAST CATHETER
FDA Adverse Event
Injury
·COVIDIEN·Product code GEI·December 8, 2025
UNKNOWN SOLITAIRE
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·December 23, 2024
UNKNOWN SOLITAIRE
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·December 23, 2024
ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
FDA Adverse Event
Malfunction
·COOK INC·Product code MIH·March 20, 2024
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