13 results
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42ms
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Sources: EU EUDAMED, US FDA
binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101
FDA Enforcement
Class II
·Ongoing·Binx Health, Inc.·May 31, 2023
binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101
FDA Recall
Open, Classified
·Binx Health, Inc.
245 1st St Ste 18
Riverview II
Cambridge MA 02142-1292·Product code QEP·March 29, 2023
Winx Health Inc
FDA registration
Winx Health Inc·8 products·🇺🇸 United States
Winx Health Inc
FDA UDI
Get Stix Inc.·00860002060415·Seven ovulation tests
Winx Health Inc
FDA UDI
Get Stix Inc.·00860002060439·Three UTI tests
Winx Health Inc
FDA UDI
Get Stix Inc.·00850024942325·Vaginal pH Tests
J&J PAPER TAPE
FDA Adverse Event
Injury
·JOHNSON & JOHNSON CONSUMER INC·Product code KGX·May 24, 2024
ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
FDA Recall
Open, Classified
·National Distribution & Contracting Inc·Product code GYB·August 24, 2021
ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs ECO 40JMC Gel Ultrasound Transmission Clr 5L 4/cs NDC P301008 ProAdvantage Gel Ultrasound Transmission 8.5 oz 12/cs NDC P301105 ProAdvantage Gel Ultrasound Transmission 5 Liter 4/cs NDC P301115 ProAdvantage Ultrasound Lotion 5L W/Empty Btl 4/cs ECO 30GS Ecogel 100 Ultrasound Grn 1in X 5L Cube 1 Dispenser Btl ECO 30GB Ecogel 100 Ultrasound Grn 8.5 oz Btl 24/cs
FDA Recall
Open, Classified
·National Distribution & Contracting Inc·Product code ITX·August 24, 2021
CS Life Sciences Europe Ltd
Authorized representative
🇮🇪 Ireland·35 Manufacturers·444 Devices
Lotus NL B.V.
Authorized representative
🇳🇱 Netherlands·584 Manufacturers·21427 Devices
CMC Medical Devices & Drugs SL
Authorized representative
🇪🇸 Spain·698 Manufacturers·11260 Devices
SUNGO Europe B.V.
Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices