16 results
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39ms
·
Sources: EU EUDAMED, US FDA
GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS
FDA 510(k)
FDA Class 2
·Neurology
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X0816400·8mm H x 16mm W x 40mm L x 0 degrees XLIF
Kalitec Disc Prep
FDA UDI
Kalitec Direct LLC·B07319K0861400·Pituitary, Straight, 3mm
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X081640120·8mm H x 16mm W x 40mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L081640120·8mm H x 16mm W x 40mm L XLIF Trial 12 degree Lo...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X08164080·8mm H x 16mm W x 40mm L x 8 degrees XLIF
Centaur Pedicle Screw System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215126636·
HANSATOME EXCELLUS MICROKERATOME
FDA 510(k)
FDA Class 1
·Ophthalmic
BIOSOFT RESIN
FDA 510(k)
FDA Class 2
·Dental
Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 11, 2019
10MM, 33CM PEEK MULTI-FUNCTION HANDLE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code KOG·April 29, 2013
ONE TOUCH ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·July 22, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 9, 2011
Femoral Nail, LEFT T2 GTN ¿12x360 mm, Product Number 18501236S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
Femoral Nail, A/R T2 Femur ¿12x360 mm, Product Number 18251236S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018