13 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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REVERE 4.5 STABILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
S 45-J
FDA UDI
BIOTRONIK SE & Co. KG·04035479144944·
2040 4 WAY SLIDE VALVE
FDA UDI
HANS RUDOLPH, INC.·00817136021089·MOD 2POS 4WAY PNEU EBS PO253
LIFEJET VIDEO LINK
FDA 510(k)
FDA Class 2
·Radiology
PERFORMAX TOTAL FACE MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
DISCOVERY RF180
FDA Adverse Event
Injury
·GENERAL MEDICAL MERATE S.P.A.·Product code JAA·August 2, 2023
PROXIMATE PLUS MD
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GDT·April 30, 2013
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014
UNKNOWN DEPUY DURALOC 300 SERIES CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 20, 2011
Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;
FDA Enforcement
Class II
·Ongoing·Ventec Life Systems, Inc.·June 30, 2021
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021