17 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Riptide Aspiration System (React 71 Catheter)
FDA 510(k)
FDA Class 2
·Cardiovascular
PFT KIT A, DISPOSABLE, QTY 100, 31 MM O.D.
FDA UDI
A-M SYSTEMS, LLC·00817081027334·Pulmonary FunctionKit A, DISPOSABLE, QTY 100, 3...
AVANOS
FDA UDI
Avanos Medical, Inc.·00193493932900·AVANOS* Single-Shot Epidural Trays
Halyard
FDA UDI
Avanos Medical, Inc.·10680651932904·HYH,EP TRY,S-SHOT,-,-,10
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668100967·DESMARRES LID RETRACTOR #1
BD¿ POSIFLUSH¿ SALINE XS 10 ML
FDA Adverse Event
Injury
·BECTON, DICKINSON AND CO.·Product code NGT·November 14, 2022
LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA
FDA 510(k)
FDA Class 1
·Neurology
BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code NGT·November 27, 2019
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·August 7, 2020
SUMMIT POR TAPER SZ3 HI OFF
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·June 21, 2013
LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·June 23, 2011
SINGLE USE SOFT-TIPPED DISPOSABLE INJECTOR
FDA Adverse Event
Malfunction
·RAYNOR INTRAOCULAR LENSES LIMITED·Product code MSS·October 14, 2014
Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198) Product Usage: The device is designed to provide regional anesthesia. The device may contain syringes, needles and drugs
FDA Enforcement
Class II
·Terminated·Kimberly-Clark Corporation·December 25, 2013
MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020
Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001
FDA Enforcement
Class II
·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021