14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IDx-DR v2.3
FDA 510(k)
FDA Class 2
·Ophthalmic
RIGIDFIX
FDA UDI
Medos International Sàrl·10886705020164·RIGIDFIX CURVE Femoral Rod Soft Tissue Only 11 ...
PAIN-AID
FDA 510(k)
FDA Class 2
·Neurology
EXCEL A.V FISUTAL NEEDLE SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD PHOENIX¿ NID
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LQM·February 12, 2024
BD PHOENIX¿ NID
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LQM·February 12, 2024
BD PHOENIX¿ NID
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LQM·February 12, 2024
UNK JUVEDERM VOLUMA
FDA Adverse Event
Injury
·ALLERGAN·Product code LMH·October 24, 2014
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·August 9, 2011
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 9, 2013
SINGLE USE ASPIRATION NEEDLE NA-U401SX
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FCG·August 4, 2021
LAPIPLASTY 4.0MM FULLY THREADED SCREW
FDA Adverse Event
Injury
·TREACE MEDICAL CONCEPTS, INC.·Product code HWC·March 14, 2025
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
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023