12 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Monarch Platform, Urology
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LuxaCore® Z Dual
FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2133340·Core build-up composite with zirconium oxide an...
PNEUMOCLEAR SMOKE EVACUATION HIGH-FLOW TUBE SET
FDA Adverse Event
Malfunction
·W.O.M. WORLD OF MEDICINE GMBH·Product code HIF·June 16, 2022
ENDOFLIP
FDA 510(k)
FDA Class 2
·Orthopedic
AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS
FDA 510(k)
FDA Class 2
·Dental
MENTOR SILTEX CONTOUR PROFILE HIGH
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·May 11, 2020
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 25, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 9, 2013
MENTOR SILTEX CONTOUR PROFILE HIGH
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·May 11, 2020
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