13 results
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29ms
·
Sources: EU EUDAMED, US FDA
AVAVA Skin Treatment System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112908·CORNEAL TREPHINE BLADE7.25MM
ARCHITECT 2nd Generation Testosterone
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE
FDA Adverse Event
Injury
·AESCULAP AG·Product code JWH·May 12, 2021
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 14, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 16, 2011
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 25, 2013
COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE
FDA Adverse Event
Injury
·AESCULAP AG·Product code KRO·December 1, 2021
AS ENDURO FEMORAL COMPONENT CEMENTED F1R
FDA Adverse Event
Injury
·AESCULAP AG·Product code JWH·September 1, 2021
ENDURO MENISCAL COMPONENT F3 10MM
FDA Adverse Event
Injury
·AESCULAP AG·Product code KRO·August 4, 2021
COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE
FDA Adverse Event
Injury
·AESCULAP AG·Product code HRZ·August 10, 2022
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024