12 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CHAMELEON FIXATION SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489125525·PowerChem Neoprene Exam Gloves, Small
PMMA disc
FDA UDI
Dentsply International Inc.·D00180714200·
Sklar®
FDA UDI
SKLAR CORPORATION·10649111125140·HOOK-ON HANDLE SS WASHABLE MED
SLIDESCAN
FDA 510(k)
FDA Class 2
·Hematology
MM-87 MOTOR-DRIVE MANIPULATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
UNK - SCREWS: TRAUMA
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·July 1, 2020
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·April 22, 2013
ASR UNI FEMORAL IMPL SIZE 55
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 13, 2011
TRIDENT HEMISPHERICAL SOLID BK
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·July 7, 2008
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 REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024