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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