10 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
FDA 510(k)
FDA Class 2
·Radiology
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704283358·LOVE RETRACTOR 45 DEGREE
ELMED
FDA UDI
ELMED INCORPORATED·00842180163980·10MM, 41CM, ESOPHAGEAL - LAP BANDING RETRACTOR,...
VALULINE
FDA UDI
BENCO DENTAL SUPPLY CO.·00366975012982·MASK VALULINE LEVEL 3 BLU BX50
KYPHON ELEMENT Inflatable Bone Tamp
FDA 510(k)
FDA Class 2
·Orthopedic
COBALT G HV BONE CEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
QUATTRODE LEAD, 3/6 MM, 30 CM
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·September 14, 2011
LOEGIA 60 ARTICULATING MED/THICK SULU
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY US SURGICAL·Product code GDW·September 3, 2014
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE HEALTH SOLUTIONS, INC·Product code LZG·July 29, 2013
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014