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

QWB 2023-11-28

Cue COVID-19 Molecular Test

Applicant Cue Health, Inc.

K-Number K232643

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GEI 2023-11-28

Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024)

Applicant Relign Corporation

K-Number K233493

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LRK 2023-11-28

C.A.R.E. Appliance (DNA, mRNA, mmRNA)

Applicant Vivos Therapeutics, Inc.

K-Number K230947

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HSN 2023-11-28

Kinos Axiom Total Ankle System

Applicant Restor3D

K-Number K232595

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GEX 2023-11-28

Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)

Applicant Wuhan Lotuxs Technology Co., Ltd.

K-Number K232117

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OVE 2023-11-28

Shoreline ACS Interbody System; Shoreline RT Interbody System

Applicant SeaSpine Orthopedics Corporation

K-Number K233414

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LZA 2023-11-28

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange)

Applicant Dehai (Shandong) Medical Gloves, Co., Ltd.

K-Number K232252

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EHD 2023-11-28

N1

Applicant Osstem Implant Co., Ltd.

K-Number K232012

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KNS 2023-11-28

Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter

Applicant Boston Scientific

K-Number K232633

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EBI 2023-11-27

PF Keep; Cad Cam Keep Block

Applicant Clemde SA DE CV

K-Number K233171

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GEH 2023-11-27

CryoThin Surgical System and Accessories

Applicant Medinux (Tianjin) Technologies Co., Ltd.

K-Number K231661

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CAF 2023-11-27

Portable (Ultrasonic) Nebulizer

Applicant Dongguan Simzo Electronic Technology Co., Ltd.

K-Number K230379

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