17 results
·
34ms
·
Sources: EU EUDAMED, US FDA
NLD IMPLANT SET
FDA 510(k)
FDA Class 1
·Ophthalmic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517369093·CoRoent LO Trial, 14x10x35mm 5°
Sunshine Diamonds
FDA UDI
Dr. Hopf GmbH & Co. KG·ESUN8133140125·Rotary diamond instruments
Sunshine Diamonds
FDA UDI
Dr. Hopf GmbH & Co. KG·ESUN8133140162·Rotary diamond instruments
Sunshine Diamonds
FDA UDI
Dr. Hopf GmbH & Co. KG·ESUN8133140142·Rotary diamond instruments
Sunshine Diamonds
FDA UDI
Dr. Hopf GmbH & Co. KG·ESUN8133140122·Rotary diamond instruments
Sunshine Diamonds
FDA UDI
Dr. Hopf GmbH & Co. KG·ESUN8133140185·Rotary diamond instruments
Sunshine Diamonds
FDA UDI
Dr. Hopf GmbH & Co. KG·ESUN8133140165·Rotary diamond instruments
Sunshine Diamonds
FDA UDI
Dr. Hopf GmbH & Co. KG·ESUN8133140145·Rotary diamond instruments
Sunshine Diamonds
FDA UDI
Dr. Hopf GmbH & Co. KG·ESUN8133140182·Rotary diamond instruments
OPIATES
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
M2A-MAGNUM PF CUP 44ODX38ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 15, 2014
SPRINT FIDELIS
FDA Adverse Event
Injury
·MPRI·Product code LWS·October 31, 2012
ROLLATOR 9153651315
FDA Adverse Event
Malfunction
·DOLOMITE AB·Product code ITJ·June 2, 2015
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018