12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Pounce Thrombectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
iTero Element 5D Plus US mobile configuration
FDA UDI
Align Technology, Inc.·00816063020752·Scanner, mobile configuration
IN TEN-S
FDA 510(k)
FDA Class 2
·Dental
ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS
FDA 510(k)
FDA Class 2
·Orthopedic
MONARCH PLATFORM
FDA Adverse Event
Injury
·AURIS HEALTH, INC.·Product code EOQ·September 6, 2022
WINGSPAN STENT SYSTEM
FDA Adverse Event
Injury
·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.·Product code NJE·October 22, 2008
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·August 15, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 8, 2013
SMR HUMERAL HEAD 52 MM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWT·October 23, 2020
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