20 results
·
35ms
·
Sources: EU EUDAMED, US FDA
GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-O
FDA 510(k)
FDA Class 2
·Dental
EVOTECH™
FDA UDI
ADVANCED STERILIZATION PRODUCTS SERVICES INC.·10705037068838·Channel Connector Tube, Brown
ROTOFIX 32 A
FDA UDI
Andreas Hettich GmbH·04050674039000·Tabletop centrifuge
K2M General Instruments
FDA UDI
VB Spine LLC·10888857551206·Offset Blade Right Size 40 mm
LEONE SPA
FDA UDI
LEONE SPA·08033707101307·BMX-MINI PALATAL EXP. DIRECT 6MMX12MM
.
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657018098·Wide Jaw Punch medium 15 degree up milled 3.5mm...
NA
FDA UDI
Summit Medical, Inc.·00385640002073·
27-120601
FDA Adverse Event
Injury
·SANTA BARBARA·Product code FTR·June 29, 2005
FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL
FDA 510(k)
FDA Class 2
·Radiology
ORTHOFLEX ROD
FDA 510(k)
FDA Class 2
·Orthopedic
POWERPICK, 30 DEG
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code GFA·May 14, 2024
UNKNOWN PRODUCT - SET SCREW
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HWC·October 12, 2012
PERMACOL 10X15 1.5MM
FDA Adverse Event
Death
·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·September 3, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 20, 2013
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·September 26, 2014
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING·Product code LXH·June 10, 2011
POWERPICK, 45 DEG
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code GFA·July 18, 2022
KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Company·July 27, 2022
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.
FDA Enforcement
Class II
·Terminated·Medrad Inc·February 27, 2013