54 results
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7ms
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Sources: EU EUDAMED, US FDA
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