26 results · 25ms · Sources: EU EUDAMED, US FDA

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XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50

FDA 510(k)
FDA Class 2 ·Radiology

SimPro™ Kit

FDA UDI
Wellspect AB·07392532194924·Single Use Urinary Catheter with water sachet. ...

Ophthalmic Hooks

FDA UDI
KATENA PRODUCTS, INC.·00841668114292·SINSKEY IOL HOOK STR (BX/3)

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04019702820935·ELVAREX 3/KNEE HIGH/CLOSED TOE-ELEPHANTIASIS-VE...

TALOS®-C

FDA UDI
SpineArt SA·07640375236715·STERILE TALOS®-C (HA) PEEK CONVEX IBFD

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B16721312308000·

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04019702999648·ELVAREX 4/THIGH HIGH/CLOSED TOE/DOTTED 2,5 CM ...

TALOS®-C HA

FDA UDI
MEDITECH SPINE, LLC·B167522308000·

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04019702777536·ELVAREX 2/KNEE HIGH/CLOSED TOE-ELEPHANTIASIS-VE...

POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

FDA 510(k)
FDA Class 1 ·General Hospital

ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES

FDA 510(k)
FDA Class 2 ·Neurology

LIBERTY CYCLER SET, SINGLE CONN EXT DL

FDA Adverse Event
Malfunction ·FRESENIUS MED CARE NORTH AMERICA REYNOSA MFG·Product code FKX·October 27, 2014

AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM

FDA Adverse Event
Injury ·C.R. BARD, INC.·Product code FTL·August 23, 2011

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013

i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

FDA Recall
Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

BD ALARIS PCA ADMINISTRATION SET

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS S.A. DE C.V.·Product code FPA·January 9, 2024

i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

FDA Enforcement
Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

BD ALARIS PCA ADMINISTRATION SET

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS S.A. DE C.V.·Product code FPA·January 9, 2024

GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed

FDA Enforcement
Class II ·Ongoing·GE Medical Systems, LLC·March 19, 2025

SIGNA Architect, Nuclear Magnetic Resonance Imaging System

FDA Enforcement
Class II ·Ongoing·GE Medical Systems, LLC·December 4, 2024