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
28441–28464 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 2017
Nasal Pancreatic Drainage Set
K171623 · FGE
Cook Ireland, Ltd.
Gastroenterology & Urology · 59d
Cleared Jul 31, 2017
Performer Introducer
K171999 · DYB
Cook Incorporated
Cardiovascular · 28d
Cleared Jul 31, 2017
Litho 60
K172025 · GEX
Quanta System Spa
General & Plastic Surgery · 26d
Cleared Jul 28, 2017
TUBETECH IV Administration Set
K162951 · FPA
Douglas Medical Products, Inc.
General Hospital · 277d
Cleared Jul 28, 2017
Smart Stitching Software System, Image Processing, Radiological
K163048 · LLZ
Osko, Inc.
Radiology · 269d
Cleared Jul 28, 2017
ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG...
K163177 · MST
Immco Diagnostics, Inc.
Immunology · 256d
Cleared Jul 28, 2017
AXS Offset Delivery Assist Catheter
K163259 · DQY
Stryker Neurovascular
Cardiovascular · 249d
Cleared Jul 28, 2017
Wheelchair
K163352 · IOR
Kunshan Hi-Fortune Health Products...
Physical Medicine · 240d
Cleared Jul 28, 2017
cobas HbA1c Test, cobas b 101 system
K163633 · LCP
Roche Diagnostics Operations
Chemistry · 218d
Cleared Jul 28, 2017
Photodynamic Therapy Device
K170187 · GEX
Uvbiotek, LLC
General & Plastic Surgery · 186d
Cleared Jul 28, 2017
Biomet Knee Joint Replacement Prostheses
K171054 · JWH
Biomet, Inc.
Orthopedic · 109d
Cleared Jul 28, 2017
Lumipulse G TSH-III Immunoreaction Cartridges
K171103 · JLW
Fujirebio Diagnostics,Inc.
Chemistry · 106d
Cleared Jul 28, 2017
Otowave 302 Portable Tympanometer
K171265 · NAS
Amplivox, Ltd.
Ear, Nose, Throat · 88d
Cleared Jul 28, 2017
Williams Cystoscopic Injection Needle
K171602 · FBK
Cook Incorporated
Gastroenterology & Urology · 57d
Cleared Jul 28, 2017
da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical...
K171699 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 50d
Cleared Jul 28, 2017
NovaPACS
K171754 · LLZ
Novarad Corporation
Radiology · 45d
Cleared Jul 28, 2017
Discovery Pico, Discovery Pico Plus
K171945 · GEX
Quanta System Spa
General & Plastic Surgery · 30d
Cleared Jul 28, 2017
VitalBeam
K172013 · IYE
Varian Medical Systems, Inc.
Radiology · 25d
Cleared Jul 27, 2017
SML-OSA2 Appliances
K162816 · LQZ
Selane Products, Inc.
Dental · 294d
Cleared Jul 27, 2017
TIGR Matrix Surgical Mesh
K163005 · OWT
Novus Scientific AB
General & Plastic Surgery · 272d
Cleared Jul 27, 2017
Bunegin-Albin Air Aspiration Set
K163031 · DXE
Cook Incorporated
Cardiovascular · 269d
Cleared Jul 27, 2017
VacLok AT Vacuum Syringe
K163597 · PUR
Merit Medical Systems, Inc.
General Hospital · 218d
Cleared Jul 27, 2017
ARIX Ankle Distal Tibia System
K170313 · HRS
Jeil Medical Corporation
Orthopedic · 176d
Cleared Jul 27, 2017
3M Comply Hydrogen Peroxide Indicator Tape
K170563 · JOJ
3M Company
General Hospital · 150d