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
23377–23400 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 2019
ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
K182123 · DJG
Advin Biotech, Inc.
Toxicology · 235d
Cleared Mar 29, 2019
Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet,...
K182164 · NHV
Ecolab, Inc.
Gastroenterology & Urology · 231d
Cleared Mar 29, 2019
Delphos Implants Rigid Fixation System
K182609 · JEY
Delphos Implants - Ind.Com....
Dental · 189d
Cleared Mar 29, 2019
Freedom Spinal Cord Stimulator (SCS) System
K182720 · GZB
Stimwave Technologies Incorporated
Neurology · 182d
Cleared Mar 29, 2019
CS-series-FP with Optional ROI Accessory CA-100S
K182834 · JAA
Omega Medical Imaging, LLC
Radiology · 171d
Cleared Mar 29, 2019
BL-Cart IOL Delivery Cartridge
K182965 · MSS
Ast Products, Inc.
Ophthalmic · 155d
Cleared Mar 29, 2019
Confirm Rx Insertable Cardiac Monitor
K182981 · MXC
Abbott
Cardiovascular · 151d
Cleared Mar 29, 2019
Thoracic VCAR with GSI Pulmonary Perfusion
K183210 · LLZ
GE Medical Systems SCS
Radiology · 130d
Cleared Mar 29, 2019
Micro Transgastric-Jejunal Feeding Device
K183508 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 101d
Cleared Mar 29, 2019
Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu...
K183579 · GZF
Boston Scientific Neuromodulation
Neurology · 98d
Cleared Mar 29, 2019
Klassic Knee System - Klassic Knee PS-Post Femur
K183596 · JWH
Total Joint Orthopedics, Inc.
Orthopedic · 98d
Cleared Mar 29, 2019
BTL-084
K190023 · PBX
BTL Industries, Inc.
General & Plastic Surgery · 84d
Cleared Mar 29, 2019
Monaco RTP System
K190178 · MUJ
Elekta, Inc.
Radiology · 56d
Cleared Mar 29, 2019
Pusen Eview Medical Video Endoscope Image Processor
K190648 · FET
Zhuhai Pusen Medical Technology Co.,...
Gastroenterology & Urology · 16d
Cleared Mar 28, 2019
V.A.C. DERMATAC Drape
K181505 · OMP
Kci USA, Inc.
General & Plastic Surgery · 294d
Cleared Mar 28, 2019
FUJIFILM Duodenoscope Model
K181745 · FDT
Fujifilm Corporation
Gastroenterology & Urology · 269d
Cleared Mar 28, 2019
Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use...
K182176 · KGO
Pt. Medisafe Technologies
General Hospital · 230d
Cleared Mar 28, 2019
Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic...
K190186 · IYO
Edan Instruments, Inc.
Radiology · 55d
Cleared Mar 28, 2019
AirSeal
K190303 · HIF
Conmed Corporation
General & Plastic Surgery · 44d
Cleared Mar 27, 2019
Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set
K181735 · LJE
Cook Incorporated
Gastroenterology & Urology · 268d
Cleared Mar 27, 2019
eKuore One electronic interface for stethoscope
K181882 · DQD
Chip Ideas Electronics S.L.
Cardiovascular · 257d
Cleared Mar 27, 2019
MiMo(TM) Negative Pressure Wound Therapy System
K181929 · OMP
Baymax Research, Inc.
General & Plastic Surgery · 252d
Cleared Mar 27, 2019
Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and...
K182738 · DKZ
Hangzhou AllTest Biotech Co., Ltd.
Toxicology · 180d
Cleared Mar 27, 2019
Accutorr 7/VS-900/VS-900c Vital Signs Monitor
K182821 · MWI
Shenzhen Mindray Bio-Medical...
Cardiovascular · 174d