Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

NKB 2019-04-08

Vitality® Spinal Fixation System

Applicant Zimmer Biomet Spine, Inc.

K-Number K183550

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MQB 2019-04-08

VIVIX-S 1751S

Applicant Vieworks Co., Ltd.

K-Number K190611

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NHA 2019-04-08

Straumann BLX Line Extension - New Abutments

Applicant Institut Straumann AG

K-Number K190040

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KTT 2019-04-08

OIC External Fixation System

Applicant Orthopaedic Implant Company

K-Number K183682

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NKB 2019-04-08

CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS®

Applicant Globus Medical, Inc.

K-Number K182375

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PGY 2019-04-08

JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor

Applicant Nanjing Jusha Display Technology Co., Ltd.

K-Number K183496

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JAK 2019-04-08

Bone VCAR (BVCAR)

Applicant GE Medical Systems SCS

K-Number K183204

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IYE 2019-04-08

Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)

Applicant Scandidos AB

K-Number K183606

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HRX 2019-04-06

MEDINAUT Plus

Applicant Imedicom Co., Ltd.

K-Number K182287

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DQY 2019-04-05

Amplatzer Trevisio Intravascular Delivery System

Applicant ABBOTT MEDICAL

K-Number K190581

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MLR 2019-04-05

V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System

Applicant STERIS Corporation

K-Number K190103

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QEY 2019-04-05

EkoSonic Endovascular Device with Control Unit 4.0

Applicant Btg International, Inc.

K-Number K183361

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