13 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Xbody Newave USA
FDA 510(k)
FDA Class 2
·Physical Medicine
Greenwald Surgical Company, Inc.
FDA UDI
GRACE MANUFACTURING, INC.·10801334009786·Otis bougie-a-boule. stainless steel
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668101070·WALTON CONJUNCTIVA RETRACTOR
SYNGO BREVIS
FDA 510(k)
FDA Class 2
·Radiology
DISPOSABLE REFLECTIVE MARKER SPHERES
FDA 510(k)
FDA Class 2
·Neurology
TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·May 31, 2019
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 18, 2013
PRESSURE INFUSION BAG
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code KZD·September 18, 2014
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORP·Product code MVK·June 29, 2011
WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·August 29, 2017
HANDLE ACETABULAR PRESS
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LXH·May 23, 2025
ACETABULAR PRESSURIZER SMALL
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LXH·May 23, 2025
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024