10,000 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Franseen Needle Marked
FDA UDI
REMINGTON MEDICAL, INC.·00813079020493·22ga (0.7mm) x 20cm
Franseen Needle Marked
FDA UDI
REMINGTON MEDICAL, INC.·00813079020486·22ga (0.7mm) x 15cm
Franseen Needle Marked
FDA UDI
REMINGTON MEDICAL, INC.·00813079020462·20ga (0.9mm) x 20cm
Franseen Needle Marked
FDA UDI
REMINGTON MEDICAL, INC.·00813079020448·20ga (0.9mm) x 9cm
Franseen Needle Marked
FDA UDI
REMINGTON MEDICAL, INC.·00813079020455·20ga (0.9mm) x 15cm
Franseen Needle Marked
FDA UDI
REMINGTON MEDICAL, INC.·00813079020479·22ga (0.7mm) x 9cm
Franseen Needle Marked
FDA UDI
REMINGTON MEDICAL, INC.·00813079020431·18ga (1.3mm) x 15cm
Medistar/Hatch (Private Label)
FDA UDI
MANAN MEDICAL PRODUCTS, INC.·00859013006031·22GA RW X 5 CM (CALIBRATED FRANSEEN WITH ECHOGE...
GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT, i) NM/CT 870 CZT O540+ 7.25MM; Emission Computed Tomography System
FDA Enforcement
Class I
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·February 15, 2023
CHIBA NEEDLE MARKED, Model CNM-1806, Size: 18 GA x 15 CM, Qty: 10 each, Remington Medical, Inc., Alpharetta, GA 30005. The device is used as a General Purpose Aspiration and Injection Needle.
FDA Recall
Terminated
·Remington Medical Inc.·Product code GDM·April 6, 2009
GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT, i) NM/CT 870 CZT O540+ 7.25MM; Emission Computed Tomography System
FDA Recall
Open, Classified
·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 19, 2022
NIMBUS 3 / DFS3
FDA Adverse Event
Malfunction
·ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB·Product code FNM·December 27, 2016
DOLPHIN FLUID IMMERSION SYSTEM
FDA Adverse Event
Injury
·AMERICAN NATIONAL·Product code FNM·August 24, 2015
DOLPHIN FLUID IMMERSION SYSTEM
FDA Adverse Event
Injury
·AMERICAN NATIONAL·Product code FNM·September 28, 2015
AUTO LOGIC
FDA Adverse Event
Injury
·GETINGE SUZHOU CO. LTD.·Product code FNM·August 13, 2015
LATERAL TURN MATTRESS W/AP AND LAL, 45 DEG Z CELL 36 X 80 X 15 9153647230
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code FNM·July 23, 2015
NIMBUS 3/ DFS3
FDA Adverse Event
Malfunction
·ARJOHUNTLEIGH POLSKA SP. ZO.O.·Product code FNM·August 13, 2015
DERMAFLOAT LAL CONTROL UNIT
FDA Adverse Event
Injury
·JOERNS HEALTHCARE·Product code FNM·July 2, 2015
DOLPHIN FLUID IMMERSION SYSTEM
FDA Adverse Event
Injury
·AMERICAN NATIONAL·Product code FNM·August 24, 2015
ALTERNATING PRESSURE AIR FLOTATION MATTRESS
FDA Adverse Event
KAP MEDICAL·Product code FNM·February 27, 2012