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
4201–4224 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 19, 2025
Leone Orthodontic Implant TAD (Temporary Anchorage Device)
K242944 · OAT
Leone S.P.A.
Dental · 267d
Cleared Jun 18, 2025
LZI Fentanyl III Enzyme Immunoassay
K251634 · DJG
Lin-Zhi International, Inc.
Toxicology · 20d
Cleared Jun 18, 2025
CONMED Argo Knotless® Anchor
K251530 · MBI
Conmed Corporation
Orthopedic · 30d
Cleared Jun 18, 2025
The Acumed Wrist Fixation System
K251296 · HRS
Acumed, LLC
Orthopedic · 54d
Cleared Jun 18, 2025
PowerPort™ isp Implantable Port
K251253 · LJT
Bard Access Systems, Inc.
General Hospital · 56d
Cleared Jun 18, 2025
Virata Spinal Fixation System
K250908 · NKB
SeaSpine Orthopedics Corporation
Orthopedic · 84d
Cleared Jun 18, 2025
EPIQ Series Diagnostic Ultrasound Systems
K250886 · IYN
Philips Ultrasound, LLC
Radiology · 85d
Cleared Jun 18, 2025
Bioline Dental Implant System
K250872 · DZE
Bioline Dental Implant Systems, Ltd.
Dental · 86d
Cleared Jun 18, 2025
Curiteva Porous PEEK Standalone ALIF System
K250845 · OVD
Curiteva, Inc.
Orthopedic · 90d
Cleared Jun 18, 2025
FlexiGo 3D Delivery Catheter
K250492 · DQY
CenterPoint Systems, LLC
Cardiovascular · 118d
Cleared Jun 18, 2025
Procedure mask/Surgical mask/Face mask
K250082 · FXX
Winner Medical Co., Ltd.
General Hospital · 156d
Cleared Jun 18, 2025
CardIQ Suite
K243672 · JAK
GE Medical Systems SCS
Radiology · 203d
Cleared Jun 18, 2025
F&P Nova Nasal Mask
K243583 · BZD
Fisher & Paykel Healthcare Limited
Anesthesiology · 210d
Cleared Jun 18, 2025
DRX9000C-SL Cervical Spinal Decompression System
K243366 · ITH
Excite Medical of Tampa Bay, LLC
Physical Medicine · 233d
Cleared Jun 18, 2025
6600 Ultrasound System (MyLabA50)
K243253 · IYN
Esaote, S.P.A.
Radiology · 246d
Cleared Jun 18, 2025
Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs
K243172 · LZA
O&M Halyard, Inc.
General Hospital · 261d
Cleared Jun 18, 2025
Mobility Scooter (JT10)
K243102 · INI
Jiangxi Jiangte Electric Vehicle Co.,...
Physical Medicine · 261d
Cleared Jun 18, 2025
Ureteral Stents (AF-D series)
K243039 · FAD
Alton (Shanghai) Medical Instruments...
Gastroenterology & Urology · 264d
Cleared Jun 18, 2025
EyeQ nanoECP
K243014 · HQF
Eyeq, Inc.
Ophthalmic · 264d
Cleared Jun 18, 2025
SPINEART Navigation Instrument System
K242933 · OLO
Spineart SA
Orthopedic · 266d
Cleared Jun 18, 2025
Extracorporeal Shock Wave Lithotripter (U200)
K242922 · LNS
Shenzhen Wikkon Precision...
Gastroenterology & Urology · 267d
Cleared Jun 18, 2025
Enteral Drainage System, Enteral Medicine straw
K242917 · PIF
Hmc Premedical S.P.A.
Gastroenterology & Urology · 267d
Cleared Jun 18, 2025
SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10)
K242894 · LFL
Shanghai Saints Sages Surgical Co., Ltd.
General & Plastic Surgery · 268d
Cleared Jun 18, 2025
Happy Health Home Sleep Test
K242224 · MNR
Happy Health, Inc.
Anesthesiology · 324d