21 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Trigon HA Stand-Alone Wedge Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Wrist Lacer
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357232260·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A22322680·22mm H x 32mm W x 26mm L x 8 degrees ALIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A223226120·22mm H x 32mm W x 26mm L x 12 degrees ALIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A223226150·22mm H x 32mm W x 26mm L x 15 degrees ALIF
TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LESSRAY
FDA 510(k)
FDA Class 2
·Radiology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 3, 2015
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 14, 2025
ENDO CLOSE
FDA Adverse Event
Injury
·US SURGICAL PUERTO RICO·Product code GCJ·April 9, 2019
SYMBOTEX MESH
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION SAS·Product code FTL·April 9, 2019
TVL ADX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·August 16, 2011
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 10, 2013
MUTLI-LINK RX TETRA CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·GUIDANT VASCULAR INTERVENTION·Product code MAF·March 22, 2007
Philips Healthcare Xper cardio systems R7.6 Model : 722133 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures
FDA Enforcement
Class II
·Terminated·Philips Medical Systems, Inc.·December 9, 2015
TRUEMETRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·May 18, 2018
UNK - SCREWS
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·October 28, 2019
UNK - SCREWS
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKB·October 28, 2019
UNK - SCREWS
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKB·October 28, 2019