13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Instrument basket, for EndoEYE
FDA 510(k)
FDA Class 2
·General Hospital
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306820861·Castroviejo Suturing Forceps, Tying Platform, T...
PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS
FDA 510(k)
FDA Class 2
·Immunology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·June 15, 2013
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 22, 2011
MEDISLIM
FDA Adverse Event
Injury
·MEDICREATIONS, LLC·Product code GEX·April 27, 2020
OPEN-END FLEXI-TIP URETERAL CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KOD·February 6, 2020
OPEN-END URETERAL CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KOD·February 7, 2020
OPEN-END URETERAL CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KOD·December 5, 2019
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·October 27, 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