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
7801–7824 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 23, 2024
AIO Breathe
K233754 · LQZ
Aiomega, LLC
Dental · 93d
Cleared Feb 23, 2024
RADspeed Pro
K233722 · KPR
Shimadzu Corporation
Radiology · 94d
Cleared Feb 23, 2024
Exceed Unlimited
K233709 · QAI
Mt. Derm GmbH
General & Plastic Surgery · 95d
Cleared Feb 23, 2024
Overjet Charting Assist
K233590 · QIH
Overjet, Inc.
Radiology · 107d
Cleared Feb 23, 2024
Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504,...
K233576 · KPI
Shenzhen Konmed Technology Co., Ltd.
Gastroenterology & Urology · 108d
Cleared Feb 23, 2024
Navigation Tracking Instruments
K232800 · OLO
SI-BONE, Inc.
Orthopedic · 164d
Cleared Feb 23, 2024
Soldier Microcatheter
K232536 · DQO
Embolx, Inc.
Cardiovascular · 186d
Cleared Feb 23, 2024
Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature...
K232228 · DJG
Shanghai Accurature Diagnostics Co.,...
Toxicology · 211d
Cleared Feb 23, 2024
rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono
K232174 · EIH
Genoss Co., Ltd.
Dental · 217d
Cleared Feb 23, 2024
StatStrip Glucose Hospital Meter System
K232075 · PZI
Nova Biomedical Corporation
Chemistry · 226d
Cleared Feb 23, 2024
CONTOUR® PLUS BLUE Blood Glucose Monitoring System
K231679 · NBW
Ascensia Diabetes Care
Chemistry · 259d
Cleared Feb 23, 2024
FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2
K231601 · DFH
Sebia
Immunology · 267d
Cleared Feb 23, 2024
Electronic Peak Flow Meter
K230423 · BZH
Taian Dalu Medical Instrument Co., Ltd.
Anesthesiology · 371d
Cleared Feb 22, 2024
Oligio X
K240313 · GEI
Wontech Co., Ltd.
General & Plastic Surgery · 20d
Cleared Feb 22, 2024
R501 - R502 aortic root cannulae with and without vent line (R501-15:...
K240193 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 29d
Cleared Feb 22, 2024
1688 4K Camera System with Advanced Imaging Modality
K240174 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 30d
Cleared Feb 22, 2024
Treace Medical Systems (TMC) Plating System
K240173 · HRS
Treace Medical Concepts, Inc.
Orthopedic · 30d
Cleared Feb 22, 2024
Ulthera System (UC-1 Control Unit PRIME)
K233996 · OHV
Ulthera, Inc.
General & Plastic Surgery · 66d
Cleared Feb 22, 2024
Vivatmo pro
K233775 · MXA
Bosch Healthcare Solutions GmbH
Chemistry · 90d
Cleared Feb 22, 2024
Revolution Ascend Sliding
K233749 · JAK
Ge Hangwei Medical Systems Co., Ltd.
Radiology · 92d
Cleared Feb 22, 2024
Segmental Plating System (SPS)
K233640 · KWQ
Alphatec Spine, Inc.
Orthopedic · 101d
Cleared Feb 22, 2024
MESHEET
K233544 · NXC
Dentis Co., Ltd.
Dental · 111d
Cleared Feb 22, 2024
Quiver Aspiration Pump
K232831 · BTA
Anoxia Medical, Inc.
General & Plastic Surgery · 162d
Cleared Feb 22, 2024
Lotus Single Lumen Ovum Aspiration Needle
K232163 · MQE
Zhejiang Horizon Medical Technology...
Obstetrics & Gynecology · 216d