27 results · 21ms · Sources: EU EUDAMED, US FDA

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ECHELON Oval V 5.0 MRI System

FDA 510(k)
FDA Class 2 ·Radiology

Vascular Probe

FDA UDI
SYNOVIS LIFE TECHNOLOGIES, INC.·00085412532554·The Vascular Probe is a sterile, single use, di...

XENMATRIX

FDA UDI
Davol Inc.·00801741074226·XenMatrix AB Surgical Graft, 10 cm x 15 cm

RUSCH

FDA UDI
TELEFLEX INCORPORATED·14026704630773·Rusch Polaris FO Blade, Miller 1.5, Sterile

OsteoMed

FDA UDI
OSTEOMED LLC·00845694040686·PrimaLIF LLIF 15mm x 18mm Lordotic Trial

STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

GUIDE CATHETERS AND ACCESSORIES

FDA 510(k)
FDA Class 2 ·Cardiovascular

EXPECT PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code EOQ·May 19, 2026

EXPECT PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code EOQ·September 24, 2025

ACQUIRE? PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code EOQ·October 10, 2025

EXPECT PULMONARY

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code EOQ·November 14, 2024

PERMACOL

FDA Adverse Event
Injury ·SOFRADIM PRODUCTION SAS·Product code FTM·September 16, 2021

EXPECT PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FCG·April 14, 2026

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code ITJ·June 6, 2013

HEAD UNKNOWN

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD·Product code KWY·June 29, 2011

VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code LOM·August 28, 2008

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

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

UNIVERSA SOFT URETERAL STENT SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FAD·January 29, 2019

UNIVERSA SOFT URETERAL STENT SET

FDA Adverse Event
Malfunction ·COOK UROLOGICAL INC·Product code FAD·May 13, 2016