35 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Bolt Intravascular Lithotripsy (IVL) System
FDA 510(k)
FDA Class 2
·Cardiovascular
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780184706·Integra® Jarit® Smith-Petersen Gouge, Straight
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690199540·Modular Knee Straight Reamer - 22mm
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776143480·Micro Biopsy Punch Forceps 5mm x 32cm
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122308·KWire .078 x 9"(2.0x225mm))
2.5MM CALIBRATED DRILL BIT QC 250MM/95MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTW·April 7, 2026
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code QBJ·March 6, 2025
Salimetrics
FDA UDI
SALIMETRICS, LLC·00859410006115·Salivary Progesterone Enzyme Immunoassay Kit (2...
HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
NovaGold High Performance Guidewire
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
2.8MM CALIBRATED DRILL BIT QC 250MM/95MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTW·August 28, 2023
2.5MM CALIBRATED DRILL BIT QC 250MM/95MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTW·April 10, 2023
2.8MM CALIBRATED DRILL BIT QC 250MM/95MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTW·February 2, 2024
DRILL BIT Ø2.5 W/STOP CALIBR L250/225
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HTW·March 29, 2022
OT VERIO IQ METER
FDA Adverse Event
LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 7, 2016
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 14, 2014
LIGHTSHEER DUET
FDA Adverse Event
Injury
·LUMENIS, INC.·Product code GEX·September 15, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 26, 2013
DRILL BIT Ø2.8 W/STOP CALIBR L250/225
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTW·April 8, 2022
2.5MM CALIBRATED DRILL BIT QC 250MM/95MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTW·September 23, 2024