FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
14065–14088 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 18, 2022
BeautiBond Xtreme
K213965 · KLE
Shofu Dental Corporation
Dental · 88d
Cleared Mar 18, 2022
15L Cycler Drainage Bag
K214016 · KDJ
Baxter Healthcare Corporation
Gastroenterology & Urology · 86d
Cleared Mar 18, 2022
Needle Stimulator (Model: RJNS6-1)
K220153 · BWK
Bozhou Rongjian Medical Appliance...
Neurology · 58d
Cleared Mar 18, 2022
Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use...
K220228 · LZA
Shandong Blue Sail Health Technology...
General Hospital · 50d
Cleared Mar 18, 2022
EMERGE Anterior Cervical Plate System
K220275 · KWQ
Evolution Spine
Orthopedic · 46d
Cleared Mar 18, 2022
CELERITY 20 HP Challenge Pack
K220473 · FRC
Steris
General Hospital · 28d
Cleared Mar 18, 2022
Merits P335 Powered Wheelchair
K220529 · ITI
Merits Health Products Co., Ltd.
Physical Medicine · 22d
Cleared Mar 18, 2022
SURGIVISIO Device
K220627 · OWB
Ecential Robotics
Radiology · 14d
Cleared Mar 17, 2022
Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use...
K210315 · GEI
Modern Medical Equipment...
General & Plastic Surgery · 407d
Cleared Mar 17, 2022
SICtapered & SICvantage tapered
K210489 · DZE
Sic Invent AG
Dental · 391d
Cleared Mar 17, 2022
Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses
K212631 · HQD
Contamac, Ltd.
Ophthalmic · 210d
Cleared Mar 17, 2022
RELIEF Ureteral Stent Kit
K213444 · FAD
Ureteral Stent Company
Gastroenterology & Urology · 143d
Cleared Mar 17, 2022
OxyMinder
K213948 · CCL
Bio-Med Devices, Inc.
Anesthesiology · 90d
Cleared Mar 16, 2022
IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat...
K210528 · MUU
Millennium Medical Technologies Inc...
General & Plastic Surgery · 386d
Cleared Mar 16, 2022
Healgen Strep A Rapid Test Strip (Throat Swab)
K212623 · GTY
Healgen Scientific, LLC
Microbiology · 210d
Cleared Mar 16, 2022
EchoSK and EchoSGyn modules for EchoS Family devices
K212851 · IYO
Echolight S.P.A
Radiology · 190d
Cleared Mar 16, 2022
iTEAR100 Neurostimulator
K213623 · QKV
Olympic Ophthalmics
Ophthalmic · 120d
Cleared Mar 16, 2022
Customize
K213779 · QIH
3D-Side S.A.
Radiology · 103d
Cleared Mar 16, 2022
Intera Refill Kit
K213823 · PTI
Intera Oncology, Inc.
General Hospital · 98d
Cleared Mar 16, 2022
AccuFit Lateral 2-Hole Plate
K220324 · KWQ
Precision Spine, Inc.
Orthopedic · 41d
Cleared Mar 16, 2022
Fiber Dust PRO
K220426 · GEX
Quanta System Spa
General & Plastic Surgery · 30d
Cleared Mar 16, 2022
K Clear
K220726 · NXC
Kline Europe GmbH
Dental · 2d
Cleared Mar 15, 2022
VITEK MS PRIME
K212461 · QBN
bioMerieux, Inc.
Microbiology · 221d
Cleared Mar 15, 2022
VoqX Electronic Stethoscope
K212709 · DQD
Sanolla , Ltd.
Cardiovascular · 201d