27 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
O'GAWA LENS DIALER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896013155·O'GAWA LENS DIALER SINGLE ENDED CURVED TIP TITA...
SafeGuide®
FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734021057·Esophageal Dilator, 21 French
Punch
FDA UDI
ELLIQUENCE, LLC·00846338002305·
O'GAWA LENS DIALER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896013087·O'GAWA LENS DIALER SINGLE ENDED
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776180409·COLLER FORCEPS . CVD. DELICATE
MaxFuse VBR, 10 (D) x 12 (W) x 43 (H)
FDA UDI
Pioneer Surgical Technology, Inc.·00846468055417·VBR, 10 (D) x 12 (W) x 43 (H)
PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708; 851318704-708, 131218204
FDA 510(k)
FDA Class 2
·Orthopedic
3004753838-2018-121421
FDA Adverse Event
Malfunction
·October 12, 2018
BI-EXT SET 15CM SMALL BORE SPIN NUT
FDA Adverse Event
Malfunction
·Product code FPA·July 9, 2021
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 19, 2025
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929064689·Corpectomy, 12Dx14Wx21H 0°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929034743·Corpectomy, 12Dx14Wx21H 6°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929059456·Convexx Corpectomy, 12Dx14Wx21H, 6°
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·September 26, 2014
LEVEL 1 HOTLINE FLUID WARMING SET WITH GAS VENT
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code LGZ·May 6, 2011
BD Q-SYTE BI-EXTENSION SET
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·March 3, 2021
Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019