27 results · 28ms · Sources: EU EUDAMED, 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