11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Nitrile Examination Gloves, Green/ Blue/ Black Color
FDA 510(k)
FDA Class 1
·General Hospital
BD Difco™ Salmonella O Antiserum Factor 34
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902117780·BD Difco™ Salmonella O Antiserum Factor 34, 3 mL
JBAIDS INFLUENZA A SUBTYPING KIT
FDA 510(k)
FDA Class 2
·Microbiology
i-STAT TBI Plasma cartridge with the i-STAT Alinity System
FDA 510(k)
FDA Class 2
·Immunology
MAVERICK2 MONORAIL PTCA CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code LOX·February 8, 2007
AROX 53-BP
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·October 24, 2008
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTL, LTD.·Product code KWA·August 10, 2011
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·July 8, 2013
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
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025