10 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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SPEEDICATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
B-P TOTAL HIP SYSTEM
FDA UDI
ENDOTEC, INC.·00814193022806·B-P HIP ACETABULAR BEARING - 32 MM I.D. X 54 MM...
CORTEZ NEEDLE FREE IV CONNECTOR, MODEL MMD-001
FDA 510(k)
FDA Class 2
·General Hospital
POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 27, 2013
PERFORMA ANGIOGRAPHIC CATHETERS
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·February 15, 2011
UNK
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code LWR·March 31, 2008
BD ULTRA FINE¿ PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·January 31, 2022
Endotec Prothesis Hip, Titanium Alloy, Sterilized. Acetabular Bearing, BP Hip System Component: 32x54 Acetabular Bearing, Catalog: 01-02-3254, 32x56 Acetabular Bearing, Catalog: 01-02-3256, Femoral Head Resurfacing Component, BP Hip System Component: 36.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0036, 38mm Femoral Head Resurfacing Component:, Catalog: 01-03-0038, 39.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0039, 41mm Femoral Head Resurfacing Component:, Catalog: 01-03-0041, 42.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0042, 44mm Femoral Head Resurfacing Component:, Catalog: 01-03-0044, 45.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0045, 47mm Femoral Head Resurfacing Component:, Catalog: 01-03-0047, 49mm Femoral Head Resurfacing Component:, Catalog: 01-03-0049, 51mm Femoral Head Resurfacing Component:, Catalog: 01-03-0051, 52mm Femoral Head Resurfacing Component:, Catalog: 01-03-0052. Femoral Stem BP Hip System Component: 10mm Femoral Stem Catalog: 01-04-0110, 11mm Femoral Stem Catalog: 01-04-0111, 12mm Femoral Stem Catalog: 01-04-0112.
FDA Recall
Terminated
·Endotec, Inc.·Product code JWH·June 5, 2009
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