12 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Country: United States
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T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 1, 2020
INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE
FDA 510(k)
FDA Class 1
·General Hospital
NYLUS PICC
FDA 510(k)
FDA Class 2
·General Hospital
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·April 29, 2024
FLEXTEND II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 7, 2011
SET SCREWDRIVER, FLEXIBLE SHAFT 4 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HXX·June 10, 2010
LIFESTENT FLEXSTAR XL BILIARY STENT
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code FGE·October 22, 2008
ASR ACETABULAR CUPS 62
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013
MEDTRONIC SURGICAL TISSUE VALVE
FDA Adverse Event
Death
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·September 22, 2022
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 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.·May 3, 2017
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023