35 results · 26ms · Sources: EU EUDAMED, US FDA

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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