17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMK, CX, CXE, RCN
FDA 510(k)
FDA Class 2
·Neurology
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809872880·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND OPEN T...
STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I
FDA 510(k)
FDA Class 2
·Clinical Toxicology
VAXCEL PORT, MODELS 45-336 AND 45-338
FDA 510(k)
FDA Class 2
·General Hospital
PLATE, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HRS·January 21, 2016
MATRIXNEURO STERILE KIT STD 4
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code JEY·December 19, 2013
TI MATRIXNEURO BURR HOLE COVER24MM
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code JEY·October 28, 2015
BLACKMAX-NEURO
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HSZ·April 3, 2013
CONTAK RENEWAL 4
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 6, 2011
MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 1U I/C
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·June 23, 2013
MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code JEY·August 28, 2015
ZNN, CMN FEMORAL NAIL, CCD 130, LEFT, 10 MM, 34 CM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·October 3, 2022
CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KTT·September 20, 2022
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
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
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