14 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110
FDA 510(k)
FDA Class 2
·General Hospital
BD ULTRA FINE¿ PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·January 31, 2022
B-P TOTAL HIP SYSTEM
FDA UDI
ENDOTEC, INC.·00814193022851·B-P HIP ACETABULAR BEARING - 32 MM I.D. X 64 MM...
MICRO STAMPING LIGATING CLIP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JIS·March 5, 2012
ACCESS® VITAMIN B12
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CDD·February 1, 2012
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·March 27, 2013
UNKNOWN ZIMMER INTERNAL FIXATION PLATE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HRS·February 15, 2011
IMPLANTIUM
FDA Adverse Event
Injury
·DENTIUM·Product code DZE·March 31, 2008
ACCESS® VITAMIN B12
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CDD·February 1, 2012
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
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
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 9, 2016