10 results · 28ms · Sources: EU EUDAMED, 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