21 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Rutner
FDA UDI
COOK INCORPORATED·00827002146815·Rutner Balloon Dilation Helical Stone Extractor
Minit®
FDA UDI
ZIMMER SPINE, INC.·00889024337558·
MedStream
FDA UDI
MEDICAL SPECIALTIES DISTRIBUTORS, LLC·00842472102406·TRACH CARE TRAY
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033468463·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033468487·
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361015864·PedFuse Remind LES, Quad, 5.5mm x 55mm
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033468470·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033468494·
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132150·Trial, TLIF, 27L OB CRV 7Deg, 15mm
3D LINE STEROTACTIC HARDWARE ACCESSORIES
FDA 510(k)
FDA Class 2
·Neurology
CAVITY VARNISH
FDA 510(k)
FDA Class 2
·Dental
DINAMAP PROCARE SERIES MONITOR
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code MWI·September 9, 2010
DINAMAP PROCARE SERIES MONITOR
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code MHX·September 9, 2010
CP87170 DE MUENCHEN
FDA Adverse Event
Death
·SORIN GROUP ITALIA·Product code DTZ·July 15, 2011
BIOMET SPLINED KNEE STEM 12X80
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·March 20, 2013
CRYOVALVE SG
FDA Adverse Event
Injury
·CRYOLIFE, INC.·Product code MIE·March 10, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 12, 2008
ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients
FDA Enforcement
Class II
·Terminated·Teleflex Medical·December 7, 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