22 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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HealthPPT
FDA 510(k)
FDA Class 2
·Radiology
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857320864·Removal Tool Size 12 mm
G-SCAN
FDA 510(k)
FDA Class 2
·Radiology
SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES
FDA 510(k)
FDA Class 2
·Microbiology
BEBACK CROSSING CATHETER
FDA Adverse Event
Malfunction
·BENTLEY INNOMED GMBH·Product code PDU·December 23, 2025
BEBACK CROSSING CATHETER
FDA Adverse Event
Malfunction
·BENTLEY INNOMED GMBH·Product code PDU·November 21, 2025
BEBACK CROSSING CATHETER
FDA Adverse Event
Malfunction
·BENTLEY INNOMED GMBH·Product code PDU·April 30, 2025
BEBACK CROSSING CATHETER
FDA Adverse Event
Malfunction
·BENTLEY INNOMED GMBH·Product code PDU·March 6, 2025
V8 Immunodisplacement Kit REF 1803
FDA Enforcement
Class II
·Ongoing·Helena Laboratories, Corp.·June 15, 2022
BATT-HANDPIECE MOD F/TRS
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code GEY·October 29, 2014
ADAPTER SLEEVES 12/14 +5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 10, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 8, 2013
V8 Immunodisplacement Kit REF 1803
FDA Recall
Open, Classified
·Helena Laboratories, Corp.·Product code CFF·April 6, 2022
Deltec Cozmo Insulin Pump, Model 1800 Smiths Medical International Ltd WD24 4LG UK, Smiths Medical MD, Inc., St Paul, MN 55112. This Pump is similar to the currently distributed Deltec Cosmo Insulin Pump Model 1700 pump, with the exception of updated software that enhanced certain features and added a food data base to allow users to better manage dietary requirements in conjunction with the use of their insulin pump. REF 21-1801-81, 21-1803-81, 21-1805-49/51/81, 21-1806-51/81, 21-1807-49
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code LZG·March 10, 2008
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
Deltec Cozmo Insulin Pump, model 21-1800. This is similar to the currently distributed Deltec Cozmo Insulin Pump Model 1700, with the exception of updated software that enhanced certain features and added a food data base to allow users to better manage dietary requirements in conjunction with the use of their insulin pump. Reorder Numbers: 21-1801-81 21-1803-81 21-1804-81 21-1805-49/51/81 21-1806-49/51/81 21-1807-49/51/81 21-1815-01/50 21-1816-01/50 21-1817-01/50
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code LZG·February 22, 2008
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
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015