17 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Biomet Headless Compression and Twist-Off Screws
FDA 510(k)
FDA Class 2
·Orthopedic
ATLANTIS® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000868086·PLATE 6190035 ANTERIOR CERVICAL 35MM
ATLANTIS® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994235848·PLATE 6190035 ANTERIOR CERVICAL 35MM
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889981169428·CORTICAL SHANK, Cannulated, 9.0 X 35
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889987169422·CORTICAL SHANK, Cannulated, 9.0 X 35
N/A
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K190055001·MTM® NO TRACE (TM) 018 UL/4-4
IN-OVATION® L
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K190055011·IN-OVATION® L 018 UPPER 6-6
IN-OVATION® L
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K190055101·IN-OVATION® L 018 UL/7-7
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327353631·DRILL BIT
Coral
FDA UDI
Seaspine Orthopedics Corporation·10889981029036·Prebent Rod 5.5 x 35
Meduloc Intramedullary Fracture Fixation (IFF) System
FDA UDI
MEDULOC, LLC·00810184540496·Removal Trephine (3.5)
INDIKO
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MODEL VISULAS 532S LASER WITH THE VITE OPTION
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
2600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 18, 2013
MERIT CUSTOM KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·September 18, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024