10 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Catalyft LS Expandable Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
Bernafon
FDA UDI
Bernafon AG·05711584114735·CZ7 MNR T, 2.4G NFM SABE DEMO CORAL 7 GPL
ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MALE LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
REVERSE #SHORT HUM. BODY 140°
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A·Product code MBF·November 11, 2022
SIGN I.M. NAIL
FDA Adverse Event
Injury
·SURGICAL IMPLANT GENERATION NETWORK (SIGN)·Product code HSB·October 24, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013
HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.
FDA Enforcement
Class II
·Terminated·HemoCue AB·September 18, 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