FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
14161–14184 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 04, 2022
Disposable Medical Surgical Mask
K212375 · FXX
Jiangxi Bestgrand Health Technology...
General Hospital · 158d
Cleared Jan 04, 2022
T-Edge 10, T-Edge 11
K213080 · FLE
Tuttnauer , Ltd.
General Hospital · 103d
Cleared Jan 04, 2022
Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle
K213831 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 27d
Cleared Jan 03, 2022
VUZE System
K210830 · LLZ
Vuze Medical , Ltd.
Radiology · 290d
Cleared Jan 03, 2022
Medline Smoke Evacuation Shroud
K213068 · FYD
Medline Industries, Inc.
General Hospital · 102d
Cleared Jan 03, 2022
Disposable Nitrile Medical Powder-free Glove
K213187 · LZA
Fujian Chunhui Medical Supply Co., Ltd.
General Hospital · 96d
Cleared Jan 02, 2022
Sterisystem Dry-Base Instrument Tray
K203177 · KCT
O&M Halyard, Inc.
General Hospital · 433d
Cleared Dec 30, 2021
Tzoar 207 Negative Pressure Wound Therapy (NPWT) System
K202898 · OMP
Lightstone Medical Products (Ningbo)...
General & Plastic Surgery · 457d
Cleared Dec 30, 2021
eco-x Series (eco-x, eco-x-s)
K211159 · OAS
Hdx Will Corp.
Radiology · 255d
Cleared Dec 30, 2021
Intrelief
K211263 · NUH
Easymed Instruments Co., Ltd.
Neurology · 248d
Cleared Dec 30, 2021
Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable...
K211458 · GDW
Ningbo Verykind Medical Device Co., Ltd.
General & Plastic Surgery · 233d
Cleared Dec 30, 2021
Quick-Start Screws
K212547 · HWC
Innovate Orthopaedics Limited
Orthopedic · 139d
Cleared Dec 30, 2021
Disposable Nitrile Medical Examination Glove (Tested for Use with...
K212834 · LZA
Siyang Threeguard Medical Supplies...
General Hospital · 114d
Cleared Dec 30, 2021
Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable...
K213538 · HQD
Acuity Polymers, Inc.
Ophthalmic · 52d
Cleared Dec 29, 2021
GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test...
K202101 · JPA
Accriva Diagnostics, Inc.
Hematology · 518d
Cleared Dec 29, 2021
CONVIVO In Vivo Pathology Suite
K211156 · LLZ
Carl Zeiss Meditec, AG
Neurology · 254d
Cleared Dec 29, 2021
Flexible Intubation Video Endoscope – Sterile (FIVE-S)
K212656 · EOQ
Karl Storz Endoscopy America
Ear, Nose, Throat · 128d
Cleared Dec 29, 2021
Goody Gloves, Wincare, TBG Gloves
K213073 · LYY
Thai Rubber Gloves Co., Ltd.
General Hospital · 97d
Cleared Dec 29, 2021
Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE...
K213316 · KOI
Nihon Kohden Corporation
Anesthesiology · 86d
Cleared Dec 29, 2021
LiverSmart
K213776 · PCS
Resonance Health Analysis Services...
Radiology · 27d
Cleared Dec 28, 2021
Alcon (serafilcon A) soft contact lenses for daily wear
K212806 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 116d
Cleared Dec 28, 2021
ATM Glove
K213016 · LZA
Phu Duc Huy Production Trading...
General Hospital · 99d
Cleared Dec 28, 2021
EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System...
K213209 · KCT
K1 Medical, LLC
General Hospital · 90d
Cleared Dec 27, 2021
Colibri System
K193138 · QQV
Copan Wasp Srl
Microbiology · 775d