11 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Towako Transmyometrial Embryo Transfer Set
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T
FDA 510(k)
FDA Class 2
·Hematology
COREN TOTAL HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AUTOPULSE NIMH BATTERY
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·June 9, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 23, 2011
ULTRASOFT LANCING DEVICE
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code FMK·September 23, 2008
HAART 200 AORTIC ANNULOPLASTY RING
FDA Adverse Event
Injury
·CORCYM INC.·Product code KRH·May 8, 2025
HAART 200 AORTIC ANNULOPLASTY RING
FDA Adverse Event
Injury
·CORCYM INC.·Product code KRH·May 9, 2025
BD ANGIOCATH¿ IV CATHETER FOR SPECIAL PLACEMENT PROCEDURES
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·December 6, 2017
Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024