20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112
FDA 510(k)
FDA Class 2
·Immunology
Healqu
FDA UDI
Healqu LLC·00819143021359·Healqu Hydrocolloid Extra Thin Dressing 2x2
MAS Urinalysis Liquid Urinalysis Control 1
FDA UDI
Microgenics Corporation·00884883004139·
ARTHROCARE CONTROLLER, PATIENT CABLE, FOOT CONTROL, POWER CORD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WISORB MALLEOLAR SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
BD BACTEC¿ MGIT¿ 960 SIRE KIT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·March 3, 2026
BD BACTEC¿ MGIT¿ 960 SIRE KIT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·March 3, 2026
BD BACTEC¿ MGIT¿ 960 SIRE KIT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·March 3, 2026
BD BACTEC¿ MGIT¿ 960 SIRE KIT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·March 3, 2026
BD BACTEC¿ MGIT¿ 960 SIRE KIT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·March 3, 2026
BD BACTEC¿ MGIT¿ 960 SIRE KIT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·March 3, 2026
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·March 27, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 18, 2011
3.5MM 90-S SERFAS ENERGY SUCTION PROBE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY PUERTO RICO·Product code GEI·March 27, 2008
PRLNE BLU 24IN 8-0 D/A BV175-6 EP
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAW·January 9, 2024
AIMING ARM/ RADIOLUCENT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·March 20, 2023
AIMING ARM/ RADIOLUCENT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code JDS·January 12, 2023
MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Part Numbers: 024222; Product is manufactured and distributed by Microgenics Corporation, a subsidiary of Thermo Fisher Scientific, Clinical Diagnostic Division, Fremont, CA MAS Urinalysis is intended for use in the clinical laboratory as a control for qualitative and semi-quantitative procedures used in routine urinalysis testing. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment. The product is suitable for use as a control material for physiochemical, chemical, and microscopic methods of routine urinalysis. Urinalysis may be used in conjunction with commercially available standardized systems for urine microscopic analysis.
FDA Enforcement
Class III
·Terminated·Thermofisher Scientive·December 4, 2013
MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Part Numbers: 024222; Product is manufactured and distributed by Microgenics Corporation, a subsidiary of Thermo Fisher Scientific, Clinical Diagnostic Division, Fremont, CA MAS Urinalysis is intended for use in the clinical laboratory as a control for qualitative and semi-quantitative procedures used in routine urinalysis testing. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment. The product is suitable for use as a control material for physiochemical, chemical, and microscopic methods of routine urinalysis. Urinalysis may be used in conjunction with commercially available standardized systems for urine microscopic analysis.
FDA Recall
Terminated
·Thermofisher Scientive·Product code JJW·October 29, 2013
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