12 results
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19ms
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Sources: EU EUDAMED, US FDA
CUSTOM DRESSING TRAY WET TO DRY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Helix
FDA UDI
Nuvasive, Inc.·00887517138958·Helix R Screw, 4x17mm Var Self-Tap
Unimed
FDA UDI
Unimed Medical Supplies, Inc.·06945664809245·Reusable SpO2 Sensor/GE TruSignal/Y-type Multi-...
ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01
FDA 510(k)
FDA Class 2
·Immunology
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BD SYRINGE¿ W/ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·May 31, 2019
MOUNTAINEER OC PLATE LARGE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code KWP·May 9, 2014
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·October 19, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 31, 2007
BD SYRINGE WITH NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·April 11, 2019
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
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024