302 results · 22ms · Sources: EU EUDAMED, US FDA

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Oscar 2

FDA 510(k)
FDA Class 2 ·Cardiovascular

Vascular Probe

FDA UDI
SYNOVIS LIFE TECHNOLOGIES, INC.·00085412532561·The Vascular Probe is a sterile, single use, di...

XENMATRIX

FDA UDI
Davol Inc.·00801741074240·XenMatrix AB Surgical Graft, 15 cm x 20 cm

Ophthalmic Forceps

FDA UDI
KATENA PRODUCTS, INC.·00841668111246·COLIBRI FORCEPS 0.12MM TITANIUM

TALOS® HA PEEK IBF

FDA UDI
MEDITECH SPINE, LLC·B167321515200·

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B167311515200·

ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014

PINNACLE MTL INS NEUT36IDX54OD

FDA Adverse Event
Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·June 7, 2013

COULTER LH750 HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·June 24, 2011

Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Vascular Probe, Item Numbers: a) 7081015, b) 7081015ES, c) 7081520, d) 7081520ES, e) 7082025, f) 7082025ES, g) 7151015, h) 7151015ES, i) 7151520, j) 7151520ES, k) 7152025, l) 7152025ES, m) 7451015, n) 7451015ES, o) 7451520, p) 7451520ES, q) 7452025, r) 7452025ES

FDA Enforcement
Class II ·Ongoing·Baxter Healthcare Corporation·April 24, 2024

BD PHOENIX¿ NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 15, 2026

BD PHOENIX¿ NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 8, 2026

BD PHOENIX¿ NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026

BD PHOENIX¿ NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026

BD PHOENIX¿ NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 15, 2026

BD PHOENIX¿ NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 19, 2026

BD PHOENIX¿ NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 19, 2026

Baxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, b) 7081520: 8CM, 1.5-2 MM GLOBAL, c) 7082025: 8CM, 2-2.5 MM GLOBAL, d) 7151015: 15CM, 1-1.5 MM GLOBAL, e) 7151520: 15CM, 1.5- 2 MM GLOBAL, f) 7152025: 15CM, 2- 2.5 MM GLOBAL, g) 7451015: 45CM, 1- 1.5 MM GLOBAL, h) 7451520: 45CM, 1.5- 2 MM GLOBAL, i) 7452025: 45CM, 2- 2.5 MM GLOBAL, j) 7081015ES: 8CM, 1-1.5 MM GLOBAL, k) 7081520ES: 8CM, 1.5- 2 MM GLOBAL, l) 7082025ES: 8CM, 2-2.5 MM GLOBAL, m) 7151015ES: 15CM, 1-1.5 MM GLOBAL, n) 7151520ES: 15CM, 1.5- 2 MM GLOBAL, o) 7152025ES: 15CM, 2-2.5 MM GLOBAL, p) 7451015ES: 45CM, 1-1.5 MM GLOBAL, q) 7451520ES: 45CM, 1.5-2 MM GLOBAL, r) 7452025ES: 45CM, 2-2.5 MM GLOBAL

FDA Enforcement
Class II ·Ongoing·Baxter Healthcare Corporation·January 17, 2024