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
7993–8016 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 2024
Trigon Trigon HA Stand-Alone Wedge Fixation System
K234116 · PLF
Nvision Biomedical Technologies
Orthopedic · 30d
Cleared Jan 26, 2024
Ziehm Solo FD
K234109 · OWB
Ziehm Imaging GmbH
Radiology · 30d
Cleared Jan 26, 2024
Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested...
K233598 · LZA
Anhui Intco Medical Products Co., Ltd.
General Hospital · 78d
Cleared Jan 26, 2024
iFuse Bedrock Granite® Implant System
K233508 · OUR
SI-BONE, Inc.
Orthopedic · 87d
Cleared Jan 26, 2024
M-Wave
K233485 · IPF
Zynex Medical, Inc.
Physical Medicine · 91d
Cleared Jan 26, 2024
ExactechGPS® System
K233299 · OLO
Blue Ortho
Orthopedic · 119d
Cleared Jan 26, 2024
EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II
K232864 · LCX
Nantong Egens Biotechnology Co., Ltd.
Chemistry · 133d
Cleared Jan 26, 2024
Disposable Hemostatic Clips
K232450 · PKL
Zhejiang Soudon Medical Technology...
Gastroenterology & Urology · 165d
Cleared Jan 26, 2024
One-Fil
K232182 · KIF
Mediclus Co., Ltd.
Dental · 186d
Cleared Jan 26, 2024
Perifit Pump
K231785 · HGX
X6 Innovations
Obstetrics & Gynecology · 220d
Cleared Jan 26, 2024
MONDRIAN™ Anterior Lumbar Plate System
K231715 · KWQ
Ctl Medical Corporation
Orthopedic · 227d
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