72 results
·
38ms
·
Sources: EU EUDAMED, US FDA
TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526189706·LEVAMED ACTIVE ANKLE SUP BLACK L I
ORTHO VLC; ORTHO VLC CAPSULE
FDA 510(k)
FDA Class 2
·Dental
SOFTSENS
FDA 510(k)
FDA Class 2
·Neurology
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 22, 2013
PINN MAR +4 10D 36IDX50OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·April 15, 2011
ASCENSIA CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·July 3, 2008
POSTERIOR PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·April 12, 2021
POSTERIOR PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·December 29, 2021
PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·June 1, 2021
GYNECARE TVT-ABBREVO MINI LCM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·November 30, 2021
ANTERIOR PELVIC FLOOR REPAIR S
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·November 18, 2021
ANTERIOR PELVIC FLOOR REPAIR S
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·November 20, 2022
GYNECARE MESH UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTM·February 11, 2021
Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mm, Model Number CM-9300; b. Quattro Drill 2.4mm, Hard Bone, Model Number CM-9324
FDA Enforcement
Class II
·Terminated·Cayenne Medical Inc.·August 8, 2018
PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·June 10, 2021
PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·April 8, 2021
POSTERIOR PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·October 13, 2021
TVT DEVICE LCM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·August 31, 2021
GYNECARE TVT OBTURATOR W LASR
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·January 6, 2021