6 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Apollo Knee Tibial Baseplate/Knee Tibial Insert: CONG TIB INS SZ0/19MM APO CONG TIB INS SZ0/22MM APO CONG TIB INS SZ1/9MM APOL CONG TIB INS SZ1/11MM APO CONG TIB INS SZ1/19MM APO CONG TIB INS SZ2/13MM APO CONG TIB INS SZ2/19MM APO CONG TIB INS SZ3/9MM APOL CONG TIB INS SZ3/13MM APO
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·March 26, 2014
Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10. Mobile X-ray System.
FDA Enforcement
Class II
·Ongoing·Olympus Scientific Solutions Americas·August 12, 2015
Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO Model/Catalog Number: CS10030, CS10040, CS10026, CS10026E Software Version: N/A Product Description: Microscope Slide Stainer IVD Component: N/A
FDA Enforcement
Class II
·Ongoing·Agilent Technologies·June 5, 2024
Olympus Scientific Solutions Americas Corporation ( OSSA ) Model: Analytical X-Ray System X -Ray Fluorescence. Intended to emit ionizing radiation Delta with models: DC-2000, DC-4000, DC-6000, DI-2000, DP-2000, DP-4000, DP-4050, DP- 6000, DPO-4000, DPO-6000, DS-2000, DS-4000, DS-6000, DS-6500, Delta, Delta 50, Delta Classic Plus, Delta Element, Delta Premium , Delta Professional , and Delta-Pl us.
FDA Enforcement
Class II
·Ongoing·Olympus Scientific Solutions Americas·August 10, 2016
Colpo-Pneumo Occluder, Part CPO-6
FDA Enforcement
Class II
·Terminated·CooperSurgical, Inc.·October 17, 2018
Kit BD Max Check-Points CPO IVD EU; Catalog # 278102
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019