19 results
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23ms
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Sources: EU EUDAMED, US FDA
GRIP LOCK ANCHOR, MODEL 411374
FDA 510(k)
FDA Class 2
·Neurology
Diamond D
FDA UDI
Keystone Industries·H66810130631·Denture Acrylic HC Lrp 1 lb P& L
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·04049958003110·400 micron Holmium Laser Fiber Cable, Single Us...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0130130·Sagittal Bender, Left
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033454268·
COUCH FOR TOTAL BODY RADIATION
FDA 510(k)
FDA Class 2
·Radiology
GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RESISTANCE FINGERTIP PROTECTION
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VNGD CR TIB BRG 12X63/67
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HRY·August 1, 2023
UNKNOWN PATELLA
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·September 1, 2023
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 1, 2013
REUNION HA FRACTURE STEM 7MM
FDA Adverse Event
Other
·STRYKER ORTHOPAEDICS MAHWAH·Product code HSD·March 1, 2011
ETS LINEAR CUTTER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 15, 2014
VNGD CR TIB BRG 12X63/67
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 3, 2023
UNKNOWN GLENOID
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·May 13, 2021
UNKNOWN HUMERAL HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·May 13, 2021
DERMATOME BLADES
FDA Adverse Event
Injury
·ZIMMER SURGICAL, INC.·Product code GFD·October 10, 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
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018