193 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
FDA Enforcement
Class II
·Ongoing·Oxoid Australia Pty Limited·April 8, 2026
SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
FDA Enforcement
Class I
·Ongoing·Glycar SA Pty., Ltd.·December 3, 2025
Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G
FDA Enforcement
Class II
·Ongoing·Ellex Medical Pty Ltd.·July 5, 2023
Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and analysis. The Seer Home System includes the Sight Monitoring Hub, the Sense wearable, Monitoring Portal and associated accessory components (Disposable EEG Wires, WaterTabs, WaterTabs Application Kit, and Take-home Kit).
FDA Enforcement
Class II
·Ongoing·SEER MEDICAL PTY LTD·September 25, 2024
SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
FDA Enforcement
Class I
·Ongoing·Glycar SA Pty., Ltd.·December 3, 2025
HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples.
FDA Enforcement
Class II
·Ongoing·Leica Biosystems Melbourne Pty Ltd·May 7, 2025
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
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