510k clearance
Scope
Date
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Bio & Pharma
Celltrion wins Australian approval for eye, bone disease biosimilars
Celltrion Inc. said Wednesday it has received regulatory approval from Australia’s Therapeutic Goods Administration (TGA) for three biosimilar...
Apr 10, 2025 (Gmt+09:00)
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Logistics
CJ Logistics, Ninja Van to co-work for cross-border e-commerce
South Korea's CJ Logistics announced on Thursday that it signed a customs clearance and delivery service contract with Singapore-based Ninja Van t...
Apr 18, 2024 (Gmt+09:00)
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Artificial intelligence
Lunit gets FDA approval for AI cancer diagnosis solution
South Korean medical AI company Lunit said on Tuesday its Lunit Insight DBT, an AI imaging diagnosis solution aiding in breast cancer diagnosis, has...
Nov 14, 2023 (Gmt+09:00)
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Bio & Pharma
S.Korea's CGBio gets FDA approval for spinal implant
CGBio, a South Korean bio-regenerative medical company, announced on Monday that its "Advanced LumFix spinal fixation system," an implant and surgic...
Aug 14, 2023 (Gmt+09:00)
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Business & Politics
Korea Customs Service to advance Tanzania's e-customs clearance system
The Korea Customs Service said on Wednesday that it has signed a memorandum of understanding (MOU) with the Tanzania Revenue Authority for cooperati...
Feb 02, 2023 (Gmt+09:00)
Latest News
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