13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Elvie Stride 2
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Breast Localization Needles
FDA UDI
ARGON MEDICAL DEVICES, INC.·00886333003679·Hawkins™ II Hardwire BLN 20ga x 12.5cm
LCP
FDA UDI
Synthes GmbH·10886982168160·4.5MM LCP® PROXIMAL FEMUR HOOK PLATE 12 HOLES/3...
Tissue Holder
FDA UDI
KATENA PRODUCTS, INC.·00841668112847·BARRON ARTIFICIAL ANTERIOR CHAMBER
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192893·12mm X 150mm Stem Pilot
AFT
FDA 510(k)
FDA Class 2
·Orthopedic
New Medax Biopsy Systems
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CLINITEK STATUS+
FDA Adverse Event
SIEMENS HEALTHCARE DIAGNOSTICS·Product code JIL·May 16, 2016
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 2, 2023
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 10, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2013
33CM DORSEY GRASPER FORCEPS, P/N 0250080319. 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