11 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MIS Angulated multi-unit abutments
FDA 510(k)
FDA Class 2
·Dental
Axium Detachable Coil; Axium Prime Detachable Coil
FDA 510(k)
FDA Class 2
·Neurology
IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G
FDA 510(k)
FDA Class 2
·Immunology
CLARIUS ULTRASOUND SCANNER
FDA Adverse Event
Malfunction
·CLARIUS MOBILE HEALTH CORP.·Product code IYN·October 17, 2024
BD CONNECTA MULTIFLO 3-WAY MULTIPLE INFUSION MANIFOLD
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·July 7, 2021
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 25, 2014
CTM ASR XL CUP 64MM X 57MM
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011
URETEX SUP URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·May 10, 2013
FISCHER CONE BIOP EX MULT
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code HGI·May 7, 2018
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