14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Multifrax Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Kitazato ET Catheter
FDA UDI
KITAZATO CORPORATION·04580745041088·
LuxaCore® Z Dual
FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2133320·Core build-up composite with zirconium oxide an...
CD-Chex Plus
FDA UDI
STRECK, INC.·30844509000090·A positive procedural control for monitoring im...
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·August 26, 2021
ON CALL CHOSEN LANCING DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 17, 2020
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
PARADIGM REAL-T9ME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 25, 2014
INRATIO
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·July 2, 2013
CustMbite, Model Number CBT-SRS-UL
FDA Enforcement
Class II
·Ongoing·Dental Choice Holding Llc·August 10, 2022
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