8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
MINI-MOTOR HAND ENGINE & ACCESS. DERMABRASION BURS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
COMPACT AUTO-SAFETY INJECTOR (CASI)
FDA 510(k)
FDA Class 2
·General Hospital
Tritanium® TL Curved Posterior Lumbar Cage
FDA 510(k)
FDA Class 2
·Orthopedic
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 14, 2014
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·October 14, 2010
11.0MM TI TROCH FIXATION NAIL SCREW/95MM - STERILE
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HSB·December 14, 2012
Shoulder Arthroscopy Pack, part number AMS2496(A Shoulder Arthroscopy Pack, part number AMS2496(B Shoulder Arthroscopy Pack, part number AMS2496(C Shoulder Arthroscopy Pack, part number AMS2609 Shoulder Arthroscopy Pack, part number AMS3857 Shoulder Arthroscopy Pack, part numbr AMS4766 Shoulder Arthroscopy Pack, part number AMS4766(A Shoulder Arthroscopy Pack, part number AMS4766(B
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
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