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
28009–28032 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 2017
PICO Single Use Negative Pressure Wound Therapy System
K172521 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 30d
Cleared Sep 20, 2017
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
K172566 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 26d
Cleared Sep 19, 2017
Finger Pulse Oximeter
K163135 · DQA
Shenzhen Fitfaith Technology Co.,Ltd
Anesthesiology · 315d
Cleared Sep 19, 2017
Digital Thermometer
K163518 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 278d
Cleared Sep 19, 2017
Pain Therapy Device
K163611 · NUH
Guangzhou Xinbo Electronic Co., Ltd.
Neurology · 271d
Cleared Sep 19, 2017
Medline Blood Collection Set
K170002 · FPA
Medline Industries, Inc.
General Hospital · 259d
Cleared Sep 19, 2017
da Vinci Xi Surgical System
K171632 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 109d
Cleared Sep 19, 2017
LigaMetrics Suture Anchors
K171964 · MBI
Mortise Medical, LLC
Orthopedic · 81d
Cleared Sep 19, 2017
ECOM™ Cardiac Output Monitoring System
K172196 · DSB
Ecom Medical, Inc.
Cardiovascular · 60d
Cleared Sep 19, 2017
ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System,...
K172199 · MAX
Medtronic Sofamor Danek
Orthopedic · 60d
Cleared Sep 19, 2017
Accordion Piccolo Stone Management Device
K172299 · FFL
Ths International, Inc. D/B/A...
Gastroenterology & Urology · 50d
Cleared Sep 18, 2017
Winback Back 3SE
K162828 · PBX
Winback USA Corp
General & Plastic Surgery · 346d
Cleared Sep 18, 2017
Shanghai Sanyou PEEK Cage System
K163422 · ODP
Shanghai Sanyou Medical Co, Ltd.
Orthopedic · 286d
Cleared Sep 18, 2017
VITROS Chemistry Products GLU Slides
K163433 · CGA
Ortho-Clinical Diagnostics
Chemistry · 285d
Cleared Sep 18, 2017
Health-e-Connect System with IDA
K163664 · NDC
Alr Technologies
General Hospital · 265d
Cleared Sep 18, 2017
LightSheer Desire
K170179 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 242d
Cleared Sep 18, 2017
Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan...
K170286 · LPL
Largan Medical Co., Ltd.
Ophthalmic · 231d
Cleared Sep 18, 2017
Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers
K172587 · ODP
Medacta International S.A.
Orthopedic · 21d
Cleared Sep 17, 2017
Endoscope Sterilization Tray
K170640 · KCT
Intuitive Surgical, Inc.
General Hospital · 199d
Cleared Sep 17, 2017
BD Cathena Safety IV Catheter
K172506 · FOZ
Becton, Dickinson and Company
General Hospital · 30d
Cleared Sep 15, 2017
A.B. DENTAL DEVICES Dental Implants System
K162482 · DZE
A.B. Dental Device , Ltd.
Dental · 374d
Cleared Sep 15, 2017
Psychemedics Microplate EIA for Benzodiazepines in Hair
K163590 · JXM
Psychemedics Corporation
Toxicology · 269d
Cleared Sep 15, 2017
neuro inspire
K163666 · HAW
Rensihaw Plc
Neurology · 262d
Cleared Sep 15, 2017
iHealth Align Gluco-Monitoring System (BG1)
K170231 · NBW
Andon Health Co, Ltd.
Chemistry · 233d