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
27841–27864 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 2017
Youha electric breast pump
K163136 · HGX
Ningbo Youhe Electrical Appliance...
Obstetrics & Gynecology · 265d
Cleared Jul 31, 2017
Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with...
K163598 · KCT
Advanced Sterilization Products
General Hospital · 222d
Cleared Jul 31, 2017
Obturys
K170207 · KIF
Itena Clinical
Dental · 188d
Cleared Jul 31, 2017
WEGO-PTFE
K170842 · NBY
Foosin Medical Supplies Inc., Ltd.
General & Plastic Surgery · 132d
Cleared Jul 31, 2017
Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD...
K171040 · ITX
Koelis
Radiology · 116d
Cleared Jul 31, 2017
Carefusion NeutraClear Needle-free connector
K171132 · FPA
Cair Lgl
General Hospital · 105d
Cleared Jul 31, 2017
Scanmate Flex
K171301 · IYO
Dgh Technology, Inc.
Radiology · 89d
Cleared Jul 31, 2017
NuBODY Skin Toning Device
K171588 · NFO
Carol Cole Company Dba Nuface
Neurology · 61d
Cleared Jul 31, 2017
Bronchi and Gastrointestinal Cytology Brush
K171607 · FDX
Wilson-Cook Medical Inc./Cook Endoscopy
Gastroenterology & Urology · 60d
Cleared Jul 31, 2017
Xingyu Nitrile Powder Free Patient Examination Gloves, White color
K171615 · LZA
Shandong Xingyu Gloves Co., Ltd.
General Hospital · 60d
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