19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SDC4K Information Management System with Device and Voice Control Package
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TALOS®-TL
FDA UDI
SpineArt SA·07640375239082·TALOS®-TL (HA) PEEK IBFD L22 W09 H08
Ormco
FDA UDI
ORMCO CORPORATION·00889989044379·CROWN-PERM LR 8 1ST MOLAR SST PK/5
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112779·BARRON VACUUM PUNCH 8.0MM
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306824326·Van Buren Urethral Sound, 24Fr, 28cm
DeBakey Ring-Bulldog Clamp S-cvd. 13cm
FDA UDI
Geister Medizintechnik GmbH·04057034052525·DeBakey Ring-Bulldog Clamp S-cvd. 13cm
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220108070·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220108000·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220108150·
APTUS PROXIMAL HUMERUS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GEO 1st MTP Joint Arthrodesis Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
FRESENIUS DIALYZER
FDA Adverse Event
Injury
·FRESENIUS USA·Product code FII·June 21, 1999
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·May 6, 2003
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 12, 2025
SILICONE ADVANCED OPTIC-VIOLET SHIELD
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·October 31, 2008
AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT
FDA Adverse Event
Malfunction
·UNITED STATES SURGICAL·Product code LFL·August 15, 2011
QUADRA ASSURA CRT-D, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 19, 2023
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025