9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
AXICUT DISPOSABLE SCALPEL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
A-FIT®
FDA UDI
Gc Orthodontics America Inc.·E53581170700001·A-FIT® 2. MOLAR UPR RGHT SZ 07
TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2
FDA 510(k)
FDA Class 2
·Physical Medicine
Everyway Wireless TENS & EMS Unit
FDA 510(k)
FDA Class 2
·Neurology
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 15, 2014
ATTAIN ABILITY
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·October 31, 2012
FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·May 29, 2015
Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024