21 results · 20ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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