10 results
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23ms
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Sources: EU EUDAMED, US FDA
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100
FDA 510(k)
FDA Class 2
·Radiology
INTERGRO DBM
FDA 510(k)
FDA Class 2
·Orthopedic
BIOMET CRANIOFACIAL ACRYLIC CEMENT
FDA 510(k)
FDA Class 2
·Neurology
WAVEWRITER ALPHA? 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 10, 2025
LAVA C.O.S. POWDER
FDA Adverse Event
Injury
·3M ESPE DENTAL PRODUCTS·Product code NOF·March 16, 2012
ACCOLADE PLUS TMZF HIP STEM #2
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·April 22, 2013
GMRS EXTENSION PIECE 80MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS LIMERICK·Product code KRO·July 3, 2008
ASR ACETABULAR CUPS 62
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 13, 2011
CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics
FDA Enforcement
Class II
·Terminated·Cytocell Ltd.·August 4, 2021
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