11 results
·
39ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Freefix Forearm Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
MAS PLIF
FDA UDI
Nuvasive, Inc.·00887517444752·MAS PLIF Fixation Rod, 55mm Pre-Bent
NA
FDA UDI
Medos International Sàrl·10886705028139·HD EP Arthroscope/Sinuscope compatible with Sto...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112489·BARRON VACUUM TREPHINE 7.25MM
Sklar®
FDA UDI
SKLAR CORPORATION·10649111092053·RICHTER-HEATH CLIP REMOVNG FCP
CYPRESS ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
GYMFORM ABS & CORE
FDA 510(k)
FDA Class 2
·Physical Medicine
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 10, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2013
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024