FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
7729–7752 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 2024
Aptima Neisseria gonorrhoeae Assay
K231329 · LSL
Hologic, Inc.
Microbiology · 263d
Cleared Jan 26, 2024
Arm-type Fully Automatic Digital Blood Pressure Monitor
K231303 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 266d
Cleared Jan 26, 2024
LifeOutcomes C-Quest™ Blood Culture Sampling Device
K231282 · JKA
Lifeoutcomes, LLC
General Hospital · 268d
Cleared Jan 25, 2024
Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable...
K234127 · LPL
CooperVision, Inc.
Ophthalmic · 28d
Cleared Jan 25, 2024
AlphaVent Knotless SP PEEK Anchor
K233893 · MBI
Stryker Endoscopy
Orthopedic · 48d
Cleared Jan 25, 2024
ADIRA™ Lateral Plate System
K233735 · KWQ
Globus Medical, Inc.
Orthopedic · 64d
Cleared Jan 25, 2024
BreView
K233714 · LLZ
GE Medical Systems SCS
Radiology · 66d
Cleared Jan 25, 2024
FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar...
K233425 · GEI
Sutter Medizintechnik GmbH
General & Plastic Surgery · 106d
Cleared Jan 25, 2024
Facet Aurora Reusable Lancet Base
K232912 · QRL
Facet Technologies, LLC
General & Plastic Surgery · 128d
Cleared Jan 25, 2024
GentleCath Air for Women (CH10)
K232665 · EZD
Convatec
Gastroenterology & Urology · 147d
Cleared Jan 25, 2024
MR Q
K232417 · HQF
Meridian AG
Ophthalmic · 167d
Cleared Jan 24, 2024
NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium
K233208 · NHA
Nobel Biocare AB
Dental · 118d
Cleared Jan 24, 2024
Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System
K233195 · IYN
Canon Medical Systems Corporation
Radiology · 118d
Cleared Jan 24, 2024
Axial3D Cloud Segmentation Service
K231607 · LLZ
Axial Medical Printing Limited
Radiology · 237d
Cleared Jan 24, 2024
Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
K231290 · DFH
The Binding Site, Ltd.
Immunology · 265d
Cleared Jan 23, 2024
2-Way 100% Silicone Cleartract Catheter
K233013 · EZL
Silq Technologies Corporation
Gastroenterology & Urology · 123d
Cleared Jan 23, 2024
Chemo Mouthpiece
K232917 · QUA
Chemo Mouthpiece, LLC
Dental · 126d
Cleared Jan 23, 2024
Dental Porcelain Powder
K232676 · EIH
Chengdu Besmile Medical Technology...
Dental · 144d
Cleared Jan 23, 2024
Dental Glass Ceramics
K232673 · EIH
Chengdu Besmile Medical Technology...
Dental · 144d
Cleared Jan 23, 2024
Endoform Dental Membrane
K231305 · NPL
Aroa Biosurgery , Ltd.
Dental · 263d
Cleared Jan 23, 2024
Nano-Check™ COVID-19 Antigen Test
K231187 · QVF
Nano-Ditech Corporation
Microbiology · 272d
Cleared Jan 23, 2024
SchurSign Tissue Marker
K230836 · NEU
Surgmark GmbH
General & Plastic Surgery · 302d
Cleared Jan 22, 2024
restor3d TIDAL Lumbar Interbody Fusion System
K234087 · MAX
Restor3d
Orthopedic · 31d
Cleared Jan 22, 2024
IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR,...
K233887 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 45d