11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRYKER SPINE AVS TL PEEK SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809870213·FOR MEN 20-30 MM HG THIGH MICRO DOT BAND OPEN T...
MULITPLE MALE LATX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
REPROCESSED HARMONIC
FDA 510(k)
FDA Unclassified
·Unknown
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 2, 2013
ACCU-CHEK ® AVIVA
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code NBW·April 6, 2011
FLEXTEND IS-1 BI POSITIVE FIX
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
NEXGEN ARTICULAR SURFACE SIZE F 10 MM HEIGHT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·June 23, 2025
Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016
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
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018