9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
COMFORT KEYBOARD SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
Posicast® Thermoplastic
FDA UDI
MEDTEC, INC.·10841439101725·LPR44 Microperfo mask with profiles
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515236592·Swiss Osteotome, 13cm, 5 1/8", 15mm edge, cvd
EXTENDED RANGE HS CRP KIT, CAT NO:9200
FDA 510(k)
FDA Class 2
·Immunology
SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code DQX·January 25, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 2, 2010
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 11, 2014
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS30; c) NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS35; d) NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS40
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024