84 results
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50ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0mm); Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline, 6 Fr/Ch (2.0 mm); Argyle" Graduated Suction Catheter Tray with Chimney Valve Sterile Saline 8 Fr/Ch (2.67 mm); Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 10 Fr/Ch (3.33 mm); Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline, Towel 14 Fr/Ch (4.67 mm); Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 14 Fr/Ch (4.67 mm); Argyle" Graduated Suction Catheter Tray with Chimney Valve Water, 8 Fr/Ch; Argyle" Suction Catheter Tray with Chimney Valve Sterile Water 12 Fr/Ch (4.00 mm); Argyle" Graduated Suction Catheter Tray with Chimney Valve, Water 14 Fr/Ch; Argyle" Suction Catheter Tray with Chimney Valve Sterile Water 10 Fr/Ch (3.33 mm); Argyle" Suction Catheter Tray with Chimney Valve Sterile Water, Towel 14 Fr/Ch (4.67 mm)
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·February 28, 2024
Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
FDA Enforcement
Class II
·Ongoing·LEICA BIOSYSTEMS NUSSLOCH GMBH·August 14, 2024
Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-274-20
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·May 10, 2023
Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·November 10, 2021
MEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed, REF MDR107002E; 2) Semi Electric Basic Homecare Bed, 4-pack,REF MDR107002E-4
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·January 28, 2026
MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E; 2) Full Electric Basic Homecare Bed, 4-pack,REF MDR107003E-4.
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·January 28, 2026
Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·April 8, 2026
Medline convenience kits containing Olympus biopsy valves: 1. BRONCH PACK, DYKE2096 2. NON MB BRONCHOPSCOPY CCH LH PK, DYNJT6182 3. PULMONARY BRONCH PACK, DYNDA2861A
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·April 8, 2026
da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS)
FDA Enforcement
Class II
·Ongoing·Intuitive Surgical, Inc.·November 2, 2022
Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate; Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm; Article Numbers: 21122-10, 21122-6, 21122-8. 4. Clavicle Plate, Lateral; Article Numbers: 21123-4, 21124-4, 21127-6, 21128-6.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026
Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY KIT, DYKM1417I DYKM1417J 3. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146A 4. RIGID KIT, DYNDA2138A
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·April 8, 2026
K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM.
FDA Enforcement
Class II
·Ongoing·Helena Laboratories, Corp.·December 23, 2020
Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions); Product Description: In vitro diagnostic chemistry analyzer.
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·July 9, 2025
Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2 to version 3.8.3 (all available software versions) Product Description: In vitro diagnostic chemistry analyzer.
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·July 9, 2025
Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD
FDA Enforcement
Class II
·Ongoing·Vortex Surgical Inc.·February 11, 2026
Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 57400 Stat Profile Prime Plus Analyzer (2) PN 59508 Stat Profile Prime Plus Analyzer, Remanufactured
FDA Enforcement
Class II
·Ongoing·Nova Biomedical Corporation·November 8, 2023
Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025
PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.
FDA Enforcement
Class II
·Ongoing·Cordis US Corp·July 20, 2022
Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000 The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (HF) patients. The system measures changes in pulmonary artery (PA) pressure which physicians use to initiate or modify heart failure treatment.
FDA Enforcement
Class II
·Ongoing·St. Jude Medical·April 2, 2025