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
11569–11592 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 2022
VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP
K221911 · IYN
Vinno Technology (Suzhou) Co.,Ltd
Radiology · 174d
Cleared Dec 21, 2022
GlucoSure ADVANCE Link Blood Glucose Monitoring System
K222234 · NBW
Apex BioTechnology Corp.
Chemistry · 148d
Cleared Dec 21, 2022
inspired™ VHB20 Heated Humidifier
K222351 · BTT
Vincent Healthcare Products Limited
Anesthesiology · 139d
Cleared Dec 21, 2022
NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter
K222538 · LOX
Sino Medical Sciences Technology, Inc.
Cardiovascular · 121d
Cleared Dec 21, 2022
Mural Clinical Viewer
K222586 · MHX
Ge Medical Systems Information...
Cardiovascular · 117d
Cleared Dec 21, 2022
TriMed Wrist Fixation System 3
K222637 · HRS
TriMed, Inc.
Orthopedic · 112d
Cleared Dec 21, 2022
8MP Color LCD Monitor CL-R813
K222864 · PGY
Jvckenwood Corporation
Radiology · 90d
Cleared Dec 21, 2022
AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)
K222867 · NUH
Andon Health Co, Ltd.
Neurology · 90d
Cleared Dec 21, 2022
AZUR HydroPack 18 (45-880005
K223050 · KRD
MicroVention, Inc.
Cardiovascular · 83d
Cleared Dec 21, 2022
Pristine Arthroscopic Visualization System
K223244 · HRX
Pristine Surgical
General & Plastic Surgery · 62d
Cleared Dec 21, 2022
reVive Light Therapy® Wrinkle and Acne LED Device
K223482 · OHS
Led Technologies, Inc.
General & Plastic Surgery · 33d
Cleared Dec 20, 2022
Bonafix 2 Plus
K213677 · DZE
Zentek Medical, LLC
Dental · 393d
Cleared Dec 20, 2022
IBS System
K220517 · DZE
Innobiosurg Co., Ltd.
Dental · 300d
Cleared Dec 20, 2022
IntelliSep test
K220991 · QUT
Cytovale, Inc.
Microbiology · 260d
Cleared Dec 20, 2022
HOPKINS Telescopes
K221004 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 259d
Cleared Dec 20, 2022
AI.ME System
K221011 · QAI
Venus Concept USA, Inc.
General & Plastic Surgery · 259d
Cleared Dec 20, 2022
Arthrex DualCompression Hindfoot Fusion Nail Implant System
K221031 · HSB
Arthrex, Inc.
Orthopedic · 257d
Cleared Dec 20, 2022
Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E,...
K221039 · FLL
Shenzhen AOJ Medical Technology Co.,...
General Hospital · 257d
Cleared Dec 20, 2022
DP4 Microneedling device
K221070 · QAI
Equipmed USA, LLC
General & Plastic Surgery · 252d
Cleared Dec 20, 2022
Kangaroo OMNI™ Enteral Feeding Pump (385400 )
K221603 · LZH
Cardinal Health, LLC
General Hospital · 201d
Cleared Dec 20, 2022
Mineral Collagen Composite Bioactive Moldable
K221735 · MQV
Collagen Matrix, Inc.
Orthopedic · 188d
Cleared Dec 20, 2022
LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)
K221775 · OHS
Light Tree Ventures Europe B.V.
General & Plastic Surgery · 182d
Cleared Dec 20, 2022
EK12 V2 Algorithm
K221904 · MHX
Ge Medical Systems Information...
Cardiovascular · 173d
Cleared Dec 20, 2022
Invictus® Bone Cement, Invictus Spinal Fixation System
K221926 · PML
Alphatec Spine, Inc.
Orthopedic · 172d