9 results
·
8ms
·
Sources: EU EUDAMED, US FDA
a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Model Number: 92210. b. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere hCG Dipstick Fertility Test hCG Pregnancy Test Urine Sample 50 Tests Model Number: 92211.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022
ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
FDA Enforcement
Class II
·Ongoing·HUMAN MED AG·March 12, 2025
Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·March 27, 2024
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·July 13, 2022
Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
FDA Enforcement
Class II
·Ongoing·FX SHOULDER·February 7, 2024