12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Air Compression Leg Massager (K-705)
FDA 510(k)
FDA Class 2
·Physical Medicine
MaXcess
FDA UDI
Nuvasive, Inc.·00887517198167·MaXcess 4 Blade, 140mm Right
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192886·14mm X 100mm Stem Pilot
OLYMPUS BF TYPE UC160-OL8
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GlucoSure Link Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
CORAIL2 LAT COXA VARA SIZE 11
FDA Adverse Event
Injury
·DEPUY FRANCE SAS-3003895575·Product code KWA·November 10, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2013
BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 28/0, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code LZO·June 30, 2021
CR TIBIAL INSERT SZ 2, 9MM, SLOPE +
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 31, 2024
PKG, 5MM SHAFT, NEEDLE HOLDER, STRAIGHT, 45CM, P/N 0250080588 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
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020