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
27025–27048 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 09, 2018
Xpert Carba-R
K173263 · POC
Cepheid
Microbiology · 90d
Cleared Jan 09, 2018
16ch T/R Hand Wrist Coil
K173469 · MOS
Quality Electrodynamics, LLC
Radiology · 62d
Cleared Jan 09, 2018
Everest Spinal System
K173508 · NKB
K2m
Orthopedic · 57d
Cleared Jan 08, 2018
Other-Sonic Transmission Gel
K163023 · MUI
Pharmaceutical Innovations, Inc.
Radiology · 434d
Cleared Jan 08, 2018
Ultra/Phonic Conductivity Gel
K163024 · MUI
Pharmaceutical Innovations, Inc.
Radiology · 434d
Cleared Jan 08, 2018
cNeuro cMRI
K171328 · LLZ
Combinostics OY
Radiology · 248d
Cleared Jan 08, 2018
PreOp
K172858 · OLX
Epilog
Neurology · 110d
Cleared Jan 08, 2018
Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein...
K172942 · KGO
Beta Healthcare Products Pvt., Ltd.
General Hospital · 104d
Cleared Jan 08, 2018
invendoscopy E210 System
K173085 · FDF
Invendo Medical GmbH
Gastroenterology & Urology · 101d
Cleared Jan 08, 2018
Cervical Spinal Truss System (CSTS) Interbody Fusion Device
K173159 · ODP
4Web, Inc.
Orthopedic · 101d
Cleared Jan 08, 2018
EVOS Small Fragment Upper Extremity Plates
K173293 · HRS
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared Jan 08, 2018
DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic
K173471 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 61d
Cleared Jan 08, 2018
Thermage CPT System and Accessories
K173759 · GEI
Solta Medical
General & Plastic Surgery · 28d
Cleared Jan 05, 2018
EON Portable Reverse Osmosis Water Purification System
K171099 · FIP
Cantel
Gastroenterology & Urology · 267d
Cleared Jan 05, 2018
STRONG Dental Handpieces
K171436 · EGS
Saeshin Precision Co., Ltd.
Dental · 234d
Cleared Jan 05, 2018
Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia...
K171518 · BSP
Zhejiang Kindly Medical Devices Co.,...
Anesthesiology · 226d
Cleared Jan 05, 2018
Electrodes with silver conductive
K171721 · GXY
Shenzhen Konmed Technology Co., Ltd.
Neurology · 207d
Cleared Jan 05, 2018
Sureclear aligners
K171860 · NXC
Emergo Global Consulting, LLC
Dental · 197d
Cleared Jan 05, 2018
Roadrunner Extra Support Wire Guide
K171948 · DQX
Cook Incorporated
Cardiovascular · 190d
Cleared Jan 05, 2018
EnsoETM
K172029 · PLA
Attune Medical
Cardiovascular · 184d
Cleared Jan 05, 2018
Pulpdent (Activa) Pit and Fissure Sealant with MCP
K172169 · EBC
Pulpdent Corporation
Dental · 171d
Cleared Jan 05, 2018
Spineology Navigation Instruments
K172518 · OLO
Spineology, Inc.
Orthopedic · 137d
Cleared Jan 05, 2018
Hair Up
K172968 · OAP
Y & J Bio Co., Ltd.
General & Plastic Surgery · 101d
Cleared Jan 05, 2018
BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam...
K173252 · LON
Becton, Dickinson and Company
Microbiology · 87d