26 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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