15 results
·
23ms
·
Sources: EU EUDAMED, US FDA
ECARE COORDINATOR (ECC)
FDA 510(k)
FDA Class 2
·Cardiovascular
HAcancellous™ PEEK-C
FDA UDI
INNO Holdings, Inc.·M711591417060·HAcancellous PEEK-C, 14L x 17W x 6H x 8°, HA PE...
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221037879·Unitek(TM) Bicuspid Band General Purpose Wide U...
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311417060·
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321417060·
K2M General Instruments
FDA UDI
VB Spine LLC·10888857583122·Modular Trial 22x8x11mm, 7°
Cadet Cervical Cage
FDA UDI
VALORUS SPINE LLC·00811771033650·Cadet Cervical Cage, 14mm x 17mm x 06mm, Non-Lo...
Cadet Cervical Cage
FDA UDI
VALORUS SPINE LLC·00811771034282·Cadet Cervical Cage, 14mm x 17mm x 06mm, 7° Lor...
VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
HOFFMANN II FOOT RING
FDA 510(k)
FDA Class 2
·Orthopedic
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 24, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 27, 2011
Zimmer Trabecular Metal Reverse Shoulder System Glenosphere, 40 mm diameter; Catalog/Ref No. 00-4349-040-01.
FDA Recall
Terminated
·Zimmer Inc.·Product code KWT·July 20, 2006
dS Breast 7ch 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024