28 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CORRIDOR4DM V2010 MODEL: V2010
FDA 510(k)
FDA Class 2
·Radiology
36M - Navajo Tribal Utility Authority
FDA UDI
Certified Safety Manufacturing, Inc.·00766588012797·36M - Navajo Tribal Utility Authority
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776186203·TC METZ SCISSORS CVD SHARPSHARP TIPS
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780375012·Integra® Jarit® Metzenbaum Scissors, 9-1/4", Ca...
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973271·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172971178·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172972991·
GT990402 DIGITAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
ENTEC EVAC PLASMA WAND
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 29, 2025
VASO VIEW HEMOPRO
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 8, 2019
PORTEX UNIPERC INNER CANNULAE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code BTO·March 16, 2020
VASOVIEW HEMOPRO 2
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 13, 2019
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 9, 2013
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014
ATTAIN OTW
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·May 24, 2011
HEMOPRO 2 ADAPTOR
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·February 21, 2020
Plastic Pack, part numbers AMS1028, AMS1028(A, and WAL1189. Product packaged in a convenient manner for use in a general clinical procedure
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·April 19, 2017
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·August 27, 2025
INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021