22 results · 28ms · Sources: EU EUDAMED, US FDA

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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