13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ES1 System
FDA 510(k)
FDA Class 2
·Radiology
Mini Twin
FDA UDI
Rmo, Inc.·00885797652751·MBT MINI LP 022 HK/345 0T CUSPID 5-5 20EA
TLC Uni Knee Tibial Plate
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215077044·
ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING
FDA 510(k)
FDA Class 2
·Radiology
WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QKP·September 18, 2020
BD RAPID DETECTION OF SARS-COV-2 VERITOR
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QKP·September 15, 2020
MUSTANG PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code LIT·August 16, 2011
CS100
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·August 4, 2014
INSIGNIA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 9, 2013
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
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021