197 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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TTDEYE (brand) Radial Pink, B16112110 - Product Usage: Colored contact lenses
FDA Enforcement
Class II
·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020
TTDEYE (brand) Devil Red, B16112201 - Product Usage: Colored contact lenses
FDA Enforcement
Class II
·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020
TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses
FDA Enforcement
Class II
·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020
TTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact lenses
FDA Enforcement
Class II
·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020
TTDEYE (brand) Diamonds Starlight, B16112203 - Product Usage: Colored contact lenses
FDA Enforcement
Class II
·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020
TTDEYE (brand) Flower Grey, B16112231 - Product Usage: Colored contact lenses
FDA Enforcement
Class II
·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020
TTDEYE (brand) Flower Brown, B16112210 - Product Usage: Colored contact lenses
FDA Enforcement
Class II
·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020
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
Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL. Lots T13664 - T14045.
FDA Enforcement
Class I
·Ongoing·QUIDEL CARDIOVASCULAR INC·July 12, 2023
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