17 results · 34ms · Sources: EU EUDAMED, US FDA

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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