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
15913–15936 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 2021
Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic...
K210618 · OCX
Chongqing Jinshan Science &...
Gastroenterology & Urology · 233d
Cleared Oct 20, 2021
Contour ProtegeAI
K210632 · QKB
Mim Software, Inc.
Radiology · 231d
Cleared Oct 20, 2021
EQ-PEX
K210789 · LQY
Meta Systems Co., Ltd.
Dental · 218d
Cleared Oct 20, 2021
MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL
K211672 · JWY
Liofilchem S. R. L.
Microbiology · 141d
Cleared Oct 20, 2021
S.I.N. Dental Implant System
K211921 · DZE
S.I.N. ? Sistema DE Implante Nacional...
Dental · 121d
Cleared Oct 20, 2021
cobas Cdiff nucleic acid test for use on the cobas Liat System
K212427 · OZN
Roche Molecular Systems, Inc.
Microbiology · 77d
Cleared Oct 20, 2021
iRAD
K212470 · LLZ
Claritas Healthtech Pte, Ltd.
Radiology · 75d
Cleared Oct 20, 2021
AVVIGO Guidance System II
K212490 · DQK
Boston Scientific Corporation
Cardiovascular · 72d
Cleared Oct 19, 2021
MyoWorx TM20
K192746 · IPF
Myoworx, Inc.
Physical Medicine · 750d
Cleared Oct 19, 2021
PICOHI
K201773 · GEX
Hironic Co., Ltd.
General & Plastic Surgery · 477d
Cleared Oct 19, 2021
Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would...
K202982 · FRO
Winner Medical Co., Ltd.
General & Plastic Surgery · 384d
Cleared Oct 19, 2021
Surgical 3D Mask
K203565 · FXX
Inno Lifecare
General Hospital · 316d
Cleared Oct 19, 2021
Synergy Gold (SG) Portable (Models MM011450 and MM011460)
K210124 · HGX
Uzinmedicare Co.
Obstetrics & Gynecology · 273d
Cleared Oct 19, 2021
Capsule Vitals Plus Patient Monitoring System
K210204 · MWI
Capsule Technologie Sas
Cardiovascular · 266d
Cleared Oct 19, 2021
Nitrile Examination Gloves
K210706 · LZA
Niujian Technology Co., Ltd.
General Hospital · 223d
Cleared Oct 19, 2021
WOLF Thrombectomy System, 14F
K210911 · QEW
Devoro Medical, Inc.
Cardiovascular · 204d
Cleared Oct 19, 2021
U9000 Plus Ultrafilter
K211035 · FIP
Baxter Healthcare Corporation
Gastroenterology & Urology · 195d
Cleared Oct 19, 2021
Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope
K211084 · DXQ
Shanghai Caremate Medical Device Co.,...
Cardiovascular · 190d
Cleared Oct 19, 2021
Single Use Irrigation bipolar cable
K211170 · GEI
Modern Medical Equipment...
General & Plastic Surgery · 183d
Cleared Oct 19, 2021
Sterile High-pressure Angiographic Syringes for Single-use
K211564 · DXT
Shenzhen Boon Medical Supply Co., Ltd.
General Hospital · 152d
Cleared Oct 19, 2021
DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)
K212254 · OAS
Hdx Will Corp.
Radiology · 92d
Cleared Oct 19, 2021
AcuPulse CO2 Laser System, Delivery Devices and Accessories
K212703 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 54d
Cleared Oct 18, 2021
Allergen-Specific IgE Assay 12 Allergen Bundle
K193613 · DHB
Hitachi Chemical Diagnostics, Inc.
Immunology · 662d
Cleared Oct 18, 2021
BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit
K201017 · PQA
Geneohm Sciences Canada, Inc. (Bd...
Microbiology · 549d