27 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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iSMILE
FDA 510(k)
FDA Class 2
·Dental
PLIF Cage
FDA UDI
Eisertech, LLC·B5231003576200908·Lordotic TPLIF Cage, Titanium 20AP X 09ML X 08H...
METZENBAUM SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896083929·METZENBAUM SCISSORS STRAIGHT BLADE POWER CUT TI...
Zavation
FDA UDI
Zavation LLC·00842166131965·Ti3Z CIF 12mmx14mmx8mm -9 deg
PLIF Cage
FDA UDI
Eisertech, LLC·B523100035200908·PLIF CAGE, NON-LORDOTIC, 20AP X 09ML X 08HT
PLIF Cage
FDA UDI
Eisertech, LLC·B523100198200908·Lordotic Bullet Nose Cage, 20AP X 09ML X 08HT
PLIF Cage
FDA UDI
Eisertech, LLC·B523100097200908·PLIF CAGE, LORDOTIC, 20AP X 09ML X 08HT
PLIF Cage
FDA UDI
Eisertech, LLC·B523100149200908·Non-Lordotic TPLIF Cage, Titanium 20AP X 09ML X...
SKYLIGHT IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
HDM97
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·December 7, 2021
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·August 5, 2015
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 11, 2011
CROSSER RECANALIZATION CATHETER
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·September 12, 2014
COMBINATION REAMER ASSEMBLY. OMEGA PLUS TI
FDA Adverse Event
Malfunction
·STRYKER TRAUMA SELZACH·Product code LXH·July 2, 2013
HLC-723 G8
FDA Adverse Event
Malfunction
·TOSOH HI-TEC, INC.·Product code PDJ·July 26, 2024
G8
FDA Adverse Event
Malfunction
·TOSOH HI-TEC, INC.·Product code PDJ·August 27, 2025
Laborie Transducer Cartridge with Luer Lock Reference: DIS130
FDA Recall
Terminated
·Laborie Medical Technologies·Product code FEN·October 4, 2006
IDS 25-Hydroxy Vitamin D EIA Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in serum or plasma. Ref: AC-57F1 Lot 60897 Exp 2009-08; Immunodiagnostic Systems Ltd, Unit 10, Boldon Business Park, Boldon, Tyne & Wear, NE35. 9PD, UK. Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in serum or plasma
FDA Recall
Terminated
·Immunodiagnostics Systems Inc·Product code MRG·August 2, 2008
Olympus Sterile Optical Laser Fiber, single use and reusable
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·June 16, 2021