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
12625–12648 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 2022
IPL sapphire ice cooling hair remove device
K221635 · OHT
Shenzhen Desida Technology Co., Ltd.
General & Plastic Surgery · 86d
Cleared Aug 31, 2022
Sterile Posterior Spinal Fixation System
K221745 · NKB
Shanghai Reach Medical Instrument Co,...
Orthopedic · 76d
Cleared Aug 31, 2022
Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20
K221955 · MUH
Realcloud Imaging Inc. Dba Realcloud...
Radiology · 57d
Cleared Aug 31, 2022
8ch Wrist Coil
K222325 · MOS
Invivo Corporation (Business Trade...
Radiology · 29d
Cleared Aug 31, 2022
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
K222387 · LNH
Canon Medical Systems Corporation
Radiology · 23d
Cleared Aug 30, 2022
Dose IQ Safety Software
K211124 · PHC
Baxter Healthcare Corporation
General Hospital · 502d
Cleared Aug 30, 2022
Novum IQ Syringe Pump
K211125 · FRN
Baxter Healthcare Corporation
General Hospital · 502d
Cleared Aug 30, 2022
Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile...
K212846 · FMF
Jiangsu Jichun Medical Devices Co., Ltd.
General Hospital · 357d
Cleared Aug 30, 2022
SOL-GUARD Safety Pull Button Collection Set
K213718 · JKA
Sol-Millennium Medical, Inc.
General Hospital · 279d
Cleared Aug 30, 2022
Riva Cem Automix
K214118 · EMA
Sdi Limited
Dental · 243d
Cleared Aug 30, 2022
Medical Surgery Mask, Model:2626-7
K220067 · FXX
Dongguan Missadola Technology Co., Ltd.
General Hospital · 232d
Cleared Aug 30, 2022
Arrow Stiffening Stylet
K220280 · DRB
Arrow International, LLC (A...
Cardiovascular · 210d
Cleared Aug 30, 2022
SaliPen
K220618 · QTT
Saliwell , Ltd.
Dental · 180d
Cleared Aug 30, 2022
JR Medic
K221157 · LZC
Jr Engineering & Medical Technologies...
General Hospital · 131d
Cleared Aug 30, 2022
Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use...
K221164 · LZA
Hong Seng Gloves Sdn Bhd
General Hospital · 130d
Cleared Aug 30, 2022
INDEX BPM
K221486 · DXN
Ya Horng Electronic Co., Ltd.
Cardiovascular · 99d
Cleared Aug 30, 2022
Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine &...
K221618 · OLO
Brainlab AG
Orthopedic · 88d
Cleared Aug 30, 2022
Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM)...
K221871 · NFT
Healstone Biotech, Inc.
Toxicology · 63d
Cleared Aug 30, 2022
Lancing device
K221970 · QRL
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 56d
Cleared Aug 30, 2022
Ultrasound Transmission Gels
K221999 · MUI
Hony Medical Co., Ltd.
Radiology · 54d
Cleared Aug 30, 2022
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
K222558 · PBK
Centers For Disease Control and...
Microbiology · 6d
Cleared Aug 29, 2022
GlucoLeader Enhance 2 Blood Glucose Monitoring System
K212248 · NBW
Hmd Biomedical, Inc.
Chemistry · 406d
Cleared Aug 29, 2022
Leaderflex Mini and Leaderflex Nano
K212370 · FOZ
Vygon USA
General Hospital · 395d
Cleared Aug 29, 2022
Blood Pressure Monitor
K220676 · DXN
Guangdong Transtek Medical...
Cardiovascular · 174d