13 results
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18ms
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Sources: EU EUDAMED, US FDA
MEDRO SPD
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5820306520·SCISSORS, SURGICAL TISSUE, DENTAL
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496030652·FRESH, SIZE ML, NOISETTE, MICRO-MASSAGING SHORT...
Atmos
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746150838·SUPPLIES ATMOS THERMOFORMING MATERIAL .030 125m...
AUER PRECISION
FDA registration
AUER PRECISION·3 products·🇺🇸 United States
SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BETEL POWDER FREE LATEX EXAM GLOVES, CHLORINATED, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
EEA 31MM SINGLE-USE STAPLER
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC PUERTO RICO·Product code GAG·March 25, 2013
ACCU-CHEK FLEXLINK PLUS INFUSION SET
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·March 22, 2011
CLEARSTAR PUMP
FDA Adverse Event
Malfunction
·ROSS PRODUCTS DIVISION·Product code LZH·April 15, 2008
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 14, 2025
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012