7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PHILIPS GYROSCAN TN 15
FDA 510(k)
FDA Class 2
·Radiology
THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
JUSTWIN SCOOTER, JS-3014
FDA 510(k)
FDA Class 2
·Physical Medicine
SPECTRANETICS LEAD LOCKING DEVICE
FDA Adverse Event
Injury
·SPECTRANETICS CORPORATION·Product code DRB·July 22, 2015
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 29, 2013
ACCU-CHEK ® ACTIVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 14, 2014
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024