12 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TOTALSHIELD SURGICAL HELMET SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AGXO
FDA UDI
Oticon A/S·05707131258311·H160, RITE 312 WL CNB AGXO
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102794·KOCH NUCLEUS CHOPPER ANGLED
UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)
FDA 510(k)
FDA Class 2
·Anesthesiology
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM
FDA 510(k)
FDA Class 3
·Obstetrics/Gynecology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·December 21, 2022
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 29, 2013
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·June 14, 2011
3003768277-2008-00023
FDA Adverse Event
Death
·Product code IZI·August 20, 2008
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012