29 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Blue
FDA 510(k)
FDA Class 1
·General Hospital
BD BBL™ Streptocard™ Acid Test Latex F
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902409304·BD BBL™ Streptocard™ Acid Test Latex F, one 2.5...
FLEXISION BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code EOQ·May 26, 2023
ZILVER BILIARY STENT SYSTEM USW
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROXIMATE CURVED CIR STAPL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 10, 2014
VASOVIEW HEMOPRO 2
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·August 17, 2011
ADVIA CENTAUR FERRITIN (FER) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code DBF·July 22, 2013
SINGLE USE GUIDEWIRE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code OCY·May 23, 2025
XVIVO Organ Chamber REF 19020
FDA Enforcement
Class II
·Terminated·XVIVO PERFUSION AB·June 8, 2022
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
FDA Enforcement
Class II
·Ongoing·Staar Surgical Company·December 13, 2023
EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
FDA Enforcement
Class II
·Ongoing·Staar Surgical Company·December 13, 2023
HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·August 13, 2025
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.
FDA Enforcement
Class II
·Ongoing·Staar Surgical Company·December 13, 2023
EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
FDA Enforcement
Class II
·Ongoing·Staar Surgical Company·December 13, 2023
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.
FDA Enforcement
Class II
·Ongoing·Staar Surgical Company·December 13, 2023
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
FDA Enforcement
Class II
·Ongoing·Staar Surgical Company·December 13, 2023
ARROW Endurance Extended Dwell Peripheral Catheter System
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·June 28, 2023
EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
FDA Enforcement
Class II
·Ongoing·Staar Surgical Company·December 13, 2023
EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.
FDA Enforcement
Class II
·Ongoing·Staar Surgical Company·December 13, 2023