11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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1717FCC
FDA 510(k)
FDA Class 2
·Radiology
Disposable Blade
FDA UDI
KATENA PRODUCTS, INC.·00841668113202·BARD-PARKER BLADE #15 PACK OF 50
ICON ADULT MANUAL
FDA 510(k)
FDA Class 1
·Physical Medicine
GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X25
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·April 10, 2024
EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code KRH·October 21, 2008
AMNISURE
FDA Adverse Event
Malfunction
·AMNISURE·Product code NQM·August 10, 2011
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 8, 2013
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system 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.·August 5, 2015
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