18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SURGITRON RADIOLASE II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NA
FDA UDI
Stryker GmbH·00886385005485·Cortical Screw, Non-Lock., Self-tap., T6 Drive
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809868005·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND OPEN T...
BENCH TOP SHIELD
FDA UDI
BIODEX MEDICAL SYSTEMS, INC.·00718175000144·SHIELD, BENCH TOP, GAMMA, ACRYLIC
Plateau-LO Spacer System
FDA UDI
Life Spine, Inc.·00190837015640·
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00811801037825·Lateral Disc Cutter, Size 10
7Pin SpO2 Extension Cable
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904003801·
DISPOSABLE POWDERED VINYL EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS (LINE EXTENSION)
FDA 510(k)
FDA Class 2
·Orthopedic
EMAX 2 MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·April 2, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·April 6, 2011
INSIGNIA ULTRA
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DXY·May 8, 2008
M2A-38 CUP NON FLARED SZ 48MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 11, 2014
PENTAX
FDA Adverse Event
Injury
·HOYA CORP.·Product code FDT·July 24, 2015
ARROW CVC SET: 2-LUMEN 4 FR X 5 CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code DQY·September 10, 2024
ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code FOZ·August 8, 2023
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
Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018