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
7777–7800 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 2024
Obsidian® NOW
K234014 · EIH
Prismatik Dentalcraft, Inc.
Dental · 70d
Cleared Feb 27, 2024
Camber Sacroiliac (SI) Fixation System
K233972 · OUR
Camber Spine Technologies
Orthopedic · 74d
Cleared Feb 27, 2024
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview...
K233879 · GEI
Maquet Cardiovascular, LLC
General & Plastic Surgery · 81d
Cleared Feb 27, 2024
Praxiject™ SP 0.9% NaCl
K233623 · NGT
Medxl, Inc.
General Hospital · 106d
Cleared Feb 27, 2024
Peace N Quiet (0.7.0)
K233435 · KLW
Pnq Health
Ear, Nose, Throat · 137d
Cleared Feb 27, 2024
4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW...
K232607 · NKB
Solco Biomedical Copany India Private...
Orthopedic · 183d
Cleared Feb 27, 2024
ARK Levetiracetam II Assay
K232522 · ORI
ARK Diagnostics, Inc.
Toxicology · 193d
Cleared Feb 27, 2024
Coresculpt & Magsculpt
K222400 · NGX
K1Med Co., Ltd.
Physical Medicine · 567d
Cleared Feb 26, 2024
Dexcom G7 Continuous Glucose Monitoring System
K234133 · QBJ
Dexcom, Inc.
General & Plastic Surgery · 59d
Cleared Feb 26, 2024
FMS VUE™ Fluid Management and Tissue Debridement System
K233675 · HRX
DePuy Mitek, Inc.
Orthopedic · 102d
Cleared Feb 26, 2024
Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential...
K233560 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 112d
Cleared Feb 26, 2024
Stone Extraction Balloon...
K232752 · GCA
Jiangsu Vedkang Medical Science and...
Gastroenterology & Urology · 171d
Cleared Feb 26, 2024
VADER® Pedicle System
K232628 · NKB
Icotec AG
Orthopedic · 181d
Cleared Feb 26, 2024
Stellaris Elite vision enhancement system
K232084 · HQC
Bausch and Lomb
Ophthalmic · 228d
Cleared Feb 26, 2024
GOLFF Sterile Anti-Fog Solution
K231822 · OCT
Batrik Medical Manufacturing, Inc.
Gastroenterology & Urology · 250d
Cleared Feb 26, 2024
TENS device-HeadaTerm 2 (Model: YF-HT2)
K230782 · PCC
Wat Medical Technology, Inc.
Neurology · 341d
Cleared Feb 26, 2024
BIS™ Advance Monitoring System
K230693 · OLW
Covidien, LLC
Anesthesiology · 350d
Cleared Feb 23, 2024
Iconix Knotless Anchor
K240213 · MBI
Riverpoint Medical
Orthopedic · 29d
Cleared Feb 23, 2024
COGNiTiON™ Staple System
K240212 · JDR
Ortho Solutions UK , Ltd.
Orthopedic · 29d
Cleared Feb 23, 2024
PathLoc SI Joint Fusion System
K240201 · OUR
L & K Biomed Co., Ltd.
Orthopedic · 29d
Cleared Feb 23, 2024
MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface,...
K240190 · DTR
Medtronic
Cardiovascular · 30d
Cleared Feb 23, 2024
Lymphedema Compression
K240011 · JOW
Jkh Health Co., Ltd.
Cardiovascular · 52d
Cleared Feb 23, 2024
Ivotion Base Print
K233995 · EBI
Ivoclar Vivadent, Inc.
Dental · 67d
Cleared Feb 23, 2024
ENSO (Model 2)
K233784 · NUH
Hinge Health, Inc.
Neurology · 88d