12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Stealth Spine Clamps; ModuLeX Shank Mounts
FDA 510(k)
FDA Class 2
·Neurology
LCP
FDA UDI
Synthes GmbH·10886982168436·LCP® VOLAR DISTAL RADIUS PLATE EXTRA-ARTICULAR ...
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113479·MINIATURE BLADE #64 (BX/5)
COGENTIX MEDICAL, INC.
FDA registration
COGENTIX MEDICAL, INC.·12 products·🇺🇸 United States
V-CORE FULL CORE BREAST BIOPSY INSTRUMENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Entriport
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED LAT STEM SIZE 5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 10, 2023
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011
GYNECARE THERMACHOICE
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code MKN·April 26, 2013
MBT CEM KEEL TIB TRAY SZ2
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code NJL·November 11, 2014
PKG, MARYLAND FORCEPS, CURVED, P/N 0250080248. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024