FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
15577–15600 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 30, 2021
Sherlock
K212664 · NHA
Open Implants, LLC
Dental · 99d
Cleared Nov 29, 2021
SeptiCyte RAPID
K203748 · PRE
Immunexpress, Inc.
Microbiology · 341d
Cleared Nov 29, 2021
ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)
K210930 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 245d
Cleared Nov 29, 2021
3D-Cut
K212237 · PBF
3D-Side S.A.
Orthopedic · 133d
Cleared CT Nov 29, 2021
geko W-2
K212762 · IPF
Firstkind Limited
Physical Medicine · 90d
Cleared Nov 29, 2021
C2 CryoBalloon Ablation System
K212814 · GEH
Pentax of America, Inc.
General & Plastic Surgery · 87d
Cleared Nov 29, 2021
RCT700
K213226 · OAS
Ray Co., Ltd.
Radiology · 61d
Cleared Nov 26, 2021
ALTMS Magnetic Stimulation Therapy System
K202537 · OBP
Remed Co., Ltd.
Neurology · 451d
Cleared Nov 26, 2021
Medical surgical mask
K202842 · FXX
Henan Huibo Medical Co., Ltd.
General Hospital · 427d
Cleared Nov 26, 2021
Tablo Cartridge
K210782 · FJK
Outset Medical, Inc.
Gastroenterology & Urology · 255d
Cleared Nov 26, 2021
Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length...
K210833 · JOH
Smiths Medical Asd, Inc.
Anesthesiology · 252d
Cleared Nov 26, 2021
CUBE Air Purifier
K211139 · FRA
Samsung Electronics Co., Ltd.
General Hospital · 224d
Cleared Nov 26, 2021
MammoScreen 2.0
K211541 · QDQ
Therapixel
Radiology · 191d
Cleared Nov 26, 2021
Trevo Trak 21 Microcatheter
K211594 · QJP
Stryker Neurovascular
Neurology · 186d
Cleared Nov 26, 2021
Synthetic Nitrile Examination Gloves
K212488 · LYZ
Shandong Hongxin Chemicals Co., Ltd.
General Hospital · 109d
Cleared Nov 26, 2021
Nitrile Examination Gloves
K212722 · LZA
Wuhan Huirui Technology Co., Ltd.
General Hospital · 91d
Cleared Nov 24, 2021
Guiding Catheter
K210009 · DQY
CenterPoint Systems, LLC
Cardiovascular · 324d
Cleared Nov 24, 2021
Bronchoscope System
K211169 · EOQ
Shanghai AnQing Medical Instrument...
Ear, Nose, Throat · 219d
Cleared Nov 24, 2021
Surgical Mask (sterile)
K211295 · FXX
Nanjing 3h Medical Products Co., Ltd.
General Hospital · 210d
Cleared Nov 24, 2021
C-30 Crown Kit
K211345 · EBF
Perfect Fit Crowns, LLC
Dental · 205d
Cleared CT Nov 24, 2021
Regulora
K211463 · QMY
Metame Health, Inc.
Gastroenterology & Urology · 197d
Cleared Nov 24, 2021
The Radian MIS Bunion System
K211650 · HRS
Nvision Biomedical Technologies, Inc.
Orthopedic · 180d
Cleared Nov 24, 2021
Non-Contact Infrared Thermometer, model HL710H
K211744 · FLL
Health & Life Co., Ltd.
General Hospital · 170d
Cleared Nov 24, 2021
Trachealator
K211894 · KTI
Disa Medinotec
Ear, Nose, Throat · 156d