19 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Fresenius Liberty Select Cycler
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RHEAD
FDA UDI
Stryker GmbH·00886385023878·Stem Trial; Extended Collar; Size 4
OVUM ASPIRATION NEEDLE SINGLE LUMEN
FDA Adverse Event
Injury
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MQE·April 19, 2018
OVUM ASPIRATION NEEDLE SINGLE LUMEN
FDA Adverse Event
Injury
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MQE·April 22, 2018
HEMOCUE WBC SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
OVUM ASPIRATION NEEDLE SINGLE LUMEN
FDA Adverse Event
Injury
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MQE·April 18, 2018
TROCHANTERIC NAIL KIT, TI GAMMA3 10X170MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 14, 2012
OVUM ASPIRATION NEEDLE SINGLE LUMEN
FDA Adverse Event
Injury
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MQE·April 19, 2018
OVUM ASPIRATION NEEDLE SINGLE LUMEN
FDA Adverse Event
Injury
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MQE·April 22, 2018
MINICAP WITH POVIDONE-IODINE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - GUANGZHOU·Product code KDI·July 21, 2011
VC SIZ 1/1 LCP COMPACT SM-FRAGM-INSTRSET
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code FSM·June 15, 2013
PINN MULTIHOLE W/GRIPTION 64MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·October 14, 2014
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
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
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