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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
12241–12264 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 2022
BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes...
K221797 · JAQ
Varian Medical Systems, Inc.
Radiology · 85d
Cleared Sep 14, 2022
GEM Biover Microvascular Clamps
K221843 · DXC
Synovis Micro Companies Alliance, Inc.
Cardiovascular · 82d
Cleared Sep 14, 2022
Arthrex SoftStitch
K222078 · GAT
Arthrex, Inc.
General & Plastic Surgery · 62d
Cleared Sep 14, 2022
Grappler Suture Anchor System
K222091 · MBI
Paragon 28, Inc.
Orthopedic · 61d
Cleared Sep 14, 2022
WatchPAT300 (WP300)
K222331 · MNR
Itamar Medical , Ltd.
Anesthesiology · 43d
Cleared Sep 14, 2022
Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip
K222503 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 27d
Cleared Sep 14, 2022
LightForce Orthodontic System
K222764 · NJM
Lightforce Orthodontics
Dental · 1d
Cleared Sep 13, 2022
MagiCath II
K210929 · FOZ
Woo Young Medical Co., Ltd.
General Hospital · 533d
Cleared Sep 13, 2022
Simplexa COVID-19 Direct
K212147 · QQX
Diasorin Molecular, LLC
Microbiology · 431d
Cleared Sep 13, 2022
Female IC (Not Finalized)
K213575 · EZD
Hollister Incorporated
Gastroenterology & Urology · 307d
Cleared Sep 13, 2022
SP-CL Hip Stem and LCU Hip System
K213770 · LZO
Waldemar Link GmbH & Co. KG
Orthopedic · 285d
Cleared Sep 13, 2022
LAITEST Medical Face Mask
K214035 · FXX
R&R Medical Corporation, Ltd.
General Hospital · 264d
Cleared Sep 13, 2022
Solid State X-ray Imager(Model: FXRD-4386WB)
K220239 · MQB
Vieworks Co., Ltd.
Radiology · 228d
Cleared Sep 13, 2022
ChoiceSpine TigerShark™ M, Modular Interbody System
K220953 · MAX
Choice Spine, LLC
Orthopedic · 165d
Cleared Sep 13, 2022
Transcutaneous Electrical Nerve Stimulator Model: ST-304
K221092 · NUH
Shenzhen Future Electronic Co., Ltd.
Neurology · 153d
Cleared Sep 13, 2022
P20 Elite Series Digital Color Doppler Ultrasound System
K221140 · IYN
Sonoscape Medical Corp.
Radiology · 147d
Cleared Sep 13, 2022
CLAROX plus (Model: VX-100)
K221417 · IZL
Vsi Co., Ltd.
Radiology · 120d
Cleared Sep 13, 2022
Primary Relief
K221425 · NHI
Dyansys, Inc.
Neurology · 120d
Cleared Sep 13, 2022
MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit
K221733 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Sep 13, 2022
Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
K221748 · KGO
Guilin Hbm Health Protections, Inc.
General Hospital · 89d
Cleared Sep 12, 2022
SOFIA 88 Catheter
K214024 · DQY
MicroVention, Inc.
Neurology · 264d
Cleared Sep 12, 2022
Infrared Forehead Thermometer
K220084 · FLL
Qingdao Yasee Medical Device Co., Ltd.
General Hospital · 245d
Cleared Sep 12, 2022
Aquilion Precision (TSX-304A/4) V10.10 with AiCE
K220986 · JAK
Canon Medical Systems Corporation
Radiology · 161d
Cleared Sep 12, 2022
Phosphoric Acid Etching Gel
K221450 · KLE
Rizhao Huge Biomaterials Company, Ltd.
Dental · 117d