10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sherlock
FDA 510(k)
FDA Class 2
·Dental
Bernafon
FDA UDI
Bernafon AG·05711584114261·AN7, BTE SP 2.4G NFM MSIL ALTENA 7 GPL
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704514469·
Sklar®
FDA UDI
SKLAR CORPORATION·10649111366642·TC GILLIES NH 5"
ZAVATION IBF SYSTEMS
FDA 510(k)
FDA Class 2
·Orthopedic
ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 29, 2008
ULTIMUM HEMOSTASIS INTRODUCER, 6F, 12CM SHEATH
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code DYB·August 10, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·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