20 results · 23ms · Sources: EU EUDAMED, 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