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
34993–35016 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 18, 2015
PeriCoach
K143580 · HIR
Analytica, Ltd.
Gastroenterology & Urology · 90d
Cleared Mar 18, 2015
U-Lite
K143601 · IYN
Sonoscanner Sarl
Radiology · 90d
Cleared Mar 18, 2015
Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack
K143651 · PGX
Focus Diagnostics, Inc.
Microbiology · 85d
Cleared Mar 18, 2015
NICAL SMART MICRO CR system for intraoral dental images
K143703 · MUH
Nical Spa
Radiology · 79d
Cleared Mar 17, 2015
Evolve UniPolar Head
K143184 · KWL
Signature Orthopaedics Pty, Ltd.
Orthopedic · 132d
Cleared Mar 17, 2015
Assurance Alar / Nasal SpO2 Sensor
K143216 · DQA
Xhale, Inc.
Anesthesiology · 127d
Cleared Mar 17, 2015
AmpliVue Trichomonas Assay
K143329 · OUY
Quidel Corporation
Microbiology · 117d
Cleared Mar 17, 2015
MiroCam Capsule Endoscope System
K143663 · NEZ
Intromedic Co., Ltd.
Gastroenterology & Urology · 84d
Cleared Mar 16, 2015
ARTEMIS LIGHT ENGINE
K141164 · NTN
Quest Medical Imaging
Gastroenterology & Urology · 315d
Cleared Mar 16, 2015
EASYDRILL AUTOSTOP CRANIAL PERFORATOR
K141455 · HBF
Micromar Ind. Com. , Ltd.
Neurology · 287d
Cleared Mar 16, 2015
O-TWO E700,O-TWO E600,O-TWO E500
K141595 · BTL
O-Two Medical Technologies, Inc.
Anesthesiology · 276d
Cleared Mar 16, 2015
ACCU-CHEK CONNECT DIABETES MANAGEMENT APP
K141929 · NDC
Roche Diagnostics Corporation
General Hospital · 243d
Cleared Mar 16, 2015
Sleepware G3
K142988 · OLZ
Respironics, Inc.
Neurology · 151d
Cleared Mar 16, 2015
Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor
K150030 · MHX
Fukuda Denshi USA, Inc.
Cardiovascular · 67d
Cleared Mar 16, 2015
InTone
K150180 · KPI
Incontrol Medical, LLC
Gastroenterology & Urology · 48d
Cleared Mar 16, 2015
NovaGold High Performance Guidewire
K150225 · OCY
Neometrics, Inc.
Gastroenterology & Urology · 42d
Cleared Mar 16, 2015
Nautilus Spinal System
K150390 · NKB
Life Spine, Inc.
Orthopedic · 26d
Cleared Mar 13, 2015
HARMONY LITE
K141237 · ONF
Alma, Inc.
General & Plastic Surgery · 304d
Cleared Mar 13, 2015
NuVasive CoRoent System
K141665 · MAX
Nuvasive, Inc.
Orthopedic · 263d
Cleared Mar 13, 2015
HOME ACCESS AIC TEST
K141944 · LCP
Home Access Health Corp.
Chemistry · 239d
Cleared Mar 13, 2015
Dental Unit
K142206 · EIA
Zhuhai Siger Medical Equipment Co., Ltd.
Dental · 214d
Cleared Mar 13, 2015
EVA,anterior machine, EVA, combined machine, EVA combined machine with...
K142877 · HQC
Dutch Ophthalmic Research Center...
Ophthalmic · 163d
Cleared Mar 13, 2015
Liquichek Maternal Serum II Control
K143379 · JJY
Bio-Rad Laboratories
Chemistry · 108d
Cleared Mar 13, 2015
Progrip Laparoscopic Self-Fixating Mesh
K143386 · FTL
Sofradim Production
General & Plastic Surgery · 107d