22 results
·
28ms
·
Sources: EU EUDAMED, US FDA
RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AVOSET INFUSION PUMP ROW
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·March 25, 2025
AVOSET INFUSION PUMP ROW
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·March 25, 2025
ISOBAR SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
N-HYBRIDE-COMPOSITE LC FLOW
FDA 510(k)
FDA Class 2
·Dental
AVOSET INFUSION PUMP ROW
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·March 25, 2025
AVOSET INFUSION PUMP ROW
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·June 22, 2025
AVOSET INFUSION PUMP ROW
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·December 23, 2025
AVOSET INFUSION PUMP ROW
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·January 5, 2026
AVOSET INFUSION PUMP ROW
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·January 5, 2026
AVOSET INFUSION PUMP ROW
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·April 29, 2026
SMR SHOULDER
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A·Product code PHX·May 18, 2026
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·October 25, 2014
URETEX TO URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·April 5, 2013
ASR ACETABULAR CUPS 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011
ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311R
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2023
ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2023
ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2023
ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2023
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