54 results · 7ms · Sources: EU EUDAMED, US FDA

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Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position.

FDA Enforcement
Class II ·Ongoing·SEDECAL SA·January 31, 2024

Vivoo Protein Test

FDA Enforcement
Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

Vivoo pH Test

FDA Enforcement
Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

Vivoo Vaginal pH Test

FDA Enforcement
Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

Menopause Test Cassette (Urine)

FDA Enforcement
Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

S. Typhi/Para Typhi A Antigen

FDA Enforcement
Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

Male Fertility Sperm Test for Home Use (Cassette)

FDA Enforcement
Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

LH One Step Ovulation Test Device (Urine)

FDA Enforcement
Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

Exploro Highly Sensitive Male Fertility / Sperm Concentration Test

FDA Enforcement
Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test

FDA Enforcement
Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein; Vivoo Ketone Test

FDA Enforcement
Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; JNW Direct 4-in-1 UTl Urinalysis Test Strips; Urinify STRENGTH; Urinify ESSENTIAL, Urinify Urinary Tract Infection (UTI)

FDA Enforcement
Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;

FDA Enforcement
Class II ·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025

18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000;

FDA Enforcement
Class II ·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025

Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;

FDA Enforcement
Class II ·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025

Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;

FDA Enforcement
Class II ·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025

Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000;

FDA Enforcement
Class II ·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025

Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF;

FDA Enforcement
Class II ·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025

9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900;

FDA Enforcement
Class II ·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025

9 Coated Regular and 9 Coated Super Tampons; Model Number: FG-TMP-REF09090000;

FDA Enforcement
Class II ·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025