27 results
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21ms
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Sources: EU EUDAMED, US FDA
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