18 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
FDA 510(k)
FDA Class 1
·General Hospital
PlaquePRO Interdental Proxy Brush
FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063755758·PlaquePRO Interdental Proxy Brush Singles - Wid...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197161787·Micro-Needle Holder
withou...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197161770·Micro-Needle Holder
withou...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197161763·Micro-Needle Holder
withou...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197161794·Micro-Needle Holder
withou...
Fine Structure Analysis(fineSA)
FDA 510(k)
FDA Class 2
·Radiology
CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Widex
FDA UDI
Widex A/S·05706069894981·WIDEX EVOKE ERB0 (Summer gold ) 100, RC coil, R...
Widex
FDA UDI
Widex A/S·05706069896404·WIDEX EVOKE E-FS (Summer gold ) 100, Telecoil, ...
Widex
FDA UDI
Widex A/S·05706069896145·WIDEX EVOKE EBB3D (Summer gold ) 100, Telecoil,...
DASHER -14 STEERABLE GUIDEWIRE
FDA Adverse Event
Injury
·NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORP·Product code DQX·January 9, 2007
33MM HEMORRHOID STAPLER 3.5MM STAPLES
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GDW·September 9, 2011
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Death
·ZOLL MANUFACTURING CORPORATION·Product code MVK·November 6, 2014
STRATA 2 VALVE, SMALL, BIOGLIDE
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·July 26, 2013
Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control that automatically configures non-adjustable treatment parameters (including time and temperature) for compatible catheters connected via a triaxial connector port. Designed for use with Venclose RF Catheters (either the EVSRF or Maven variants) as an integrated system, the device employs resistive radiofrequency ablation to deliver temperature-controlled RF energy that heats incompetent vein walls, inducing irreversible luminal occlusion followed by progressive fibrosis and eventual vein resorption. The 510(k) submission K250068 encompasses solely the Venclose digiRF Generator due to software modifications with no alterations to the cleared Venclose Catheters (EVSRF and Maven variants, cleared under K160754 and K211806, respectively).
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·October 8, 2025
Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control that automatically configures non-adjustable treatment parameters (including time and temperature) for compatible catheters connected via a triaxial connector port. Designed for use with Venclose RF Catheters (either the EVSRF or Maven variants) as an integrated system, the device employs resistive radiofrequency ablation to deliver temperature-controlled RF energy that heats incompetent vein walls, inducing irreversible luminal occlusion followed by progressive fibrosis and eventual vein resorption. The 510(k) submission K250068 encompasses solely the Venclose digiRF Generator due to software modifications with no alterations to the cleared Venclose Catheters (EVSRF and Maven variants, cleared under K160754 and K211806, respectively).
FDA Recall
Open, Classified
·Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
850 W. Rio Salado Prkwy.
Tempe AZ 85281-2438·Product code GEI·August 21, 2025
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012