23 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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Celerity Incubator
FDA 510(k)
FDA Class 2
·General Hospital
Glisten Adult Toothbrush
FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063755710·Glisten Adult Toothbrush, compact power point h...
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780455691·Integra® Jarit® Cobb Style Osteotome, Curved
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036037123·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197492782·Jacobson Micro Scissors
14mm l...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197155670·Jacobson Micro Scissors, 14mm blades
8mm ro...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197539104·Castroviejo Micro Scissors,8mm roundhand
11.5cm...
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011250061400·ceraMotion® Zr Incisal 2, 40 g / dental ceramic...
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011250061200·ceraMotion® Zr Incisal 2, 20 g / dental ceramic...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197539111·Jacobson Micro Scissors
14mm l...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197152907·Castroviejo Micro Scissors,8mm roundhand
11.5cm...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197524674·Jacobson Micro Scissors, 14mm blades
8mm ro...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197539098·Micro Scissors 120mm/4 3/4"
9mm lo...
Lucent; Lucent Ti-Bond Systems
FDA 510(k)
FDA Class 2
·Orthopedic
HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 8, 2025
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 15, 2011
POLARIS ADJUSTABLE VALVE KIT
FDA Adverse Event
Malfunction
·SOPHYSA SA·Product code JXG·August 21, 2013
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 23, 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