10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DeGen Navigated Instrumentation
FDA 510(k)
FDA Class 2
·Neurology
MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·October 7, 2014
ECHELON*FLEX60 COMPACT
FDA Adverse Event
Death
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 17, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 9, 2013
SHARPS COLL 8QT NEST OPEN TOP NEEDL PORT
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·April 27, 2020
HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019
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