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Showing 161–180 of 1734 results

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H Pylori Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Pregnancy Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Drug Test Small (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

Moderate

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Neurotransmitters XL (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Pet Allergy Test (GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden) – distribution without premarket approv... (2025)

Distribution without premarket approval/clearance.

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Food Sensitivity Test Medium (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Sorbitol Intolerance Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Peptic Ulcer Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

PSA Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

GI Microbiome Profile XL (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Menopause Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

SIBO Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Candida Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

3 in 1 STI Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Continuous Glucose Monitor (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

NICO Myriad Illumination Pack (Stryker) – Latex Contamination Risk (2025)

Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.

FDAOct 31, 2025Nationwide• Stryker Corporation

IntelliVue Multi-Measurement Module X3 (Philips) – monitoring alarm issue (2025)

Potential issue where the IntelliVue monitors did not alarm.

FDAOct 31, 2025Nationwide• Philips North America Llc

IntelliVue Patient Monitor MX400 (Philips) – monitoring alarm issue (2025)

Potential issue where the IntelliVue monitors did not alarm.

FDAOct 31, 2025Nationwide• Philips North America Llc

IntelliVue MP20 (Philips) – Alarm Failure Risk (2025)

Potential issue where the IntelliVue monitors did not alarm.

FDAOct 31, 2025Nationwide• Philips North America Llc

Olympus OER-Mini (Aizu Olympus) – Maintenance Warning (2025)

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

FDAOct 31, 2025Nationwide• Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan

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