14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Tamper Evident Cap
FDA 510(k)
FDA Class 2
·General Hospital
Unity Total Knee System
FDA UDI
CORIN LTD·05056139233180·Unity ASC Tibial Insert Trials Size 7 to 9 9-14...
MONOBLOC REAMER 9.5mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665000818·
SENSE BODY COIL
FDA 510(k)
FDA Class 2
·Radiology
DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
SENSORMEDICS
FDA Adverse Event
Death
·CARDINAL HEALTH 207, INC.·Product code LSZ·November 14, 2008
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·August 26, 2011
GYNECARE PROLIFT +M ANTERIOR PELVIC FLOOR REPAIR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·July 17, 2013
UNKN ENT REFLEX ULTRA PLASMA WAND AND TURBINATOR WAND
FDA Adverse Event
Injury
·ARTHROCARE CORP.·Product code GEI·September 22, 2022
BD MICRO-FINE¿ + INSULIN SYRINGE WITH NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·November 10, 2017
BD MICRO-FINE¿ INSULIN SYRINGE WITH NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·July 6, 2018
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025