33 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA, Order Number G57682; Reference Part Number C-PTIS-100-UNL-HC-G-EU, Order Number G57687; Reference Part Number C-PTIS-100-UNS-HC-G-EU, Order Number G57686.
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·April 15, 2026
Am I Pregnant? One Step HCG Pregnancy Test REF 100-17
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704.
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·April 15, 2026
AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
FDA Enforcement
Class II
·Ongoing·PerkinElmer Life and Analytical Sciences, Wallac, OY·May 8, 2019
AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
FDA Enforcement
Class II
·Ongoing·PerkinElmer Life and Analytical Sciences, Wallac, OY·May 8, 2019
DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.
FDA Enforcement
Class II
·Ongoing·PerkinElmer Life and Analytical Sciences, Wallac, OY·May 8, 2019
Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy. Model/Catalog Number: 1004
FDA Enforcement
Class II
·Ongoing·Princeton Biomeditech Corp·November 6, 2024
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G-EU-FLEX8.5 (G57696), C-PTIS-100-HC-G-NA-FLEX7.5 (G57691), C-PTIS-100-HC-G-NA-FLEX8.5 (G57692)
FDA Enforcement
Class I
·Ongoing·Cook Incorporated·May 17, 2023
DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725), C-PTISYJ-100-HC-G-NA-FLEX7.5 (G57720), C-PTISYJ-100-HC-G-NA-FLEX8.5 (G57721), C-PTISY-100-HC-G-NA-FLEX8.5 (G57717), C-PTISY-100-HC-G-NA-FLEX7.5 (G57716)
FDA Enforcement
Class I
·Ongoing·Cook Incorporated·May 17, 2023
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
DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
a. McKesson Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Serum / Urine Sample 25 Tests. Model Number: 5002. b. McKesson Consult Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Urine Sample 25 Tests Model Number: 5000. c. McKesson Medical-Surgical McKesson TEST KIT, PREG HCG CASSETTE WAIVED Model Number: 5001
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022
Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin, Osmolality, pH, Phosphate Inorganic, Potassium, Protein Total, Sodium, Specific Gravity, Urea and Uric Acid (Urate) on clinical chemistry systems Catalog Number: UC5074
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·August 30, 2023
IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·May 4, 2022
Lem Fertility hCG Pregnancy Urine Test REF 100-12
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
DiagnosUS Pregnancy Test Midstream REF 100-17
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023