172 results
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7ms
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Sources: EU EUDAMED, US FDA
Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
FDA Enforcement
Class II
·Ongoing·XTANT Medical Holdings, Inc·October 23, 2024
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·May 21, 2025
Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·July 14, 2021
Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·July 14, 2021
Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·July 14, 2021
Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
FDA Enforcement
Class II
·Ongoing·Atrium Medical Corporation·November 22, 2023
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·December 31, 2025
Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI A/C; (3)3650-100 DRAIN, OASIS BRU W/AC;
FDA Enforcement
Class II
·Ongoing·Atrium Medical Corporation·November 22, 2023
OMTMO One Step Ovulation (LH) Test Strips REF 200-07
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR; (3)2002-100 DRAIN, OCEAN SINGLE W/AC; (4)2002-300 DRAIN, OCEAN SINGLE W/S; (5) 2002-400 DRAIN, OCEAN SINGLE ; (6)2012-320 DRAIN, OCEAN PEDI W/S; (7)2050-000 DRAIN, OCEAN BRU W/AC,S
FDA Enforcement
Class II
·Ongoing·Atrium Medical Corporation·November 22, 2023
PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
Lem Fertility LH Ovulation Test (Strip) REF 200-07
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
Lem Fertility hCG Pregnancy Urine Test REF 100-12
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
DiagnosUS Pregnancy Test Midstream REF 100-17
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
One Step Pregnancy Test REF 100-01
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023