10 results
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25ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING
FDA Enforcement
Class I
·Ongoing·Universal Meditech Inc.·February 8, 2023
Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
FDA Enforcement
Class I
·Ongoing·SML Distribution, LLC·May 11, 2022
Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·May 28, 2014
Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
FDA Enforcement
Class II
·Terminated·Aesculap Implant Systems LLC·November 2, 2016
C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·August 21, 2013
C-QUR TacShield Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·August 21, 2013
C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·August 21, 2013
C-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·August 21, 2013
Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C; b) CAN KIT, REF DYKM1184; c) DENTAL CDS, REF CDS984010B; d) EGD KIT, REF DYK1253578F; e) EGD REG KIT, REF DYKE1830; f) ENDO KIT, REF DYKE1516A; g) ERCP REG KIT, REF DYKM2127; h) GI PACK, REF DYKE1898; i) KIT, PEG, REG, REF DYKM2128; j) KIT,1500CC, 50CS, REF DYKM2126; k) LITHOTOMY, REF DYNJ909937; l) MAJOR BASIC, REF DYNJ909703; m) MINOR GENERAL SURGERY, REF DYNJ909940; n) SUCTION SET UP KIT, REF DYKM1187A; o) TURNOVER KIT, REF DYKC1274A; p) TURNOVER KIT MKT STRAPS, REF DYKC1309A; q) U BAR, REF DYNJ902374K
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 28, 2024
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·December 24, 2025