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
5233–5256 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 2024
Porous Biologic Scaffold
K240765 · MQV
Ventris Medical
Orthopedic · 273d
Cleared Dec 18, 2024
FirstFit Surgical Kit
K240763 · EWL
Freudenberg Medical, LLC
Ear, Nose, Throat · 273d
Cleared Dec 17, 2024
Sentinel Camera
K243664 · HKI
Ai Optics
Ophthalmic · 20d
Cleared Dec 17, 2024
Healgen Accurate Muti-Drug Urine Drug Screen Cup
K243365 · NGL
Healgen Scientific, LLC
Toxicology · 49d
Cleared Dec 17, 2024
Lucitone Digital Print Denture™ System
K243336 · EBI
Dentsply Sirona, Inc.
Dental · 54d
Cleared Dec 17, 2024
Thulium Fiber Laser (FiberLAZE+, FiberLAZE)
K242987 · GEX
Allengers Global Healthcare Private...
General & Plastic Surgery · 82d
Cleared Dec 17, 2024
prodisc® L Instruments
K242869 · QLQ
Centinel Spine, LLC
Orthopedic · 88d
Cleared Dec 17, 2024
Quantium
K242816 · EBF
Bisco, Inc.
Dental · 90d
Cleared Dec 17, 2024
POCKET TENS (EP-300)
K242815 · NUH
Hivox Biotek, Inc.
Neurology · 90d
Cleared Dec 17, 2024
Roche Digital Pathology Dx
K242783 · PSY
Ventana Medical Systems, Inc.
Pathology · 92d
Cleared Dec 17, 2024
Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology,...
K242558 · LZA
O&M Halyard, Inc.
General Hospital · 111d
Cleared Dec 17, 2024
VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily...
K242413 · LPL
Vizionfocus, Inc.
Ophthalmic · 125d
Cleared Dec 17, 2024
Reform Pedicle Screw System
K242297 · NKB
Precision Spine, Inc.
Orthopedic · 137d
Cleared Dec 17, 2024
BIOBRANE Temporary Wound Dressing
K242146 · KGN
Smith & Nephew Medical Limited
General & Plastic Surgery · 147d
Cleared Dec 17, 2024
Tornus ES
K241801 · FGE
Asahi Intecc Co., Ltd.
Gastroenterology & Urology · 179d
Cleared Dec 17, 2024
ALLONUS Tech Prosthetics
K241616 · NHA
Allonus Tech Co., Ltd.
Dental · 195d
Cleared Dec 17, 2024
Cardiac Workstation (5000)
K241556 · DPS
Philips Medizin Systeme B?blingen GmbH
Cardiovascular · 200d
Cleared Dec 17, 2024
Autoclave Indicator Tape
K241036 · JOJ
Jiangmen New Era External Use Drug...
General Hospital · 245d
Cleared Dec 17, 2024
Cntrl+ Bladder Support Pessary
K240798 · HHW
Cntrl+, Inc.
Gastroenterology & Urology · 270d
Cleared Dec 17, 2024
Aptiva APS IgG Reagent
K223093 · MID
Inova Diagnostics, Inc.
Immunology · 809d
Cleared Dec 16, 2024
da Vinci Surgical System (IS5000)
K243641 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 20d
Cleared Dec 16, 2024
Extraction Basket
K243471 · LQR
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 38d
Cleared Dec 16, 2024
Dental Implants and Abutments
K243066 · DZE
Ditron Dental, Ltd.
Dental · 80d
Cleared Dec 16, 2024
ACHIEVE Partial Knee System
K242307 · NJD
Ignite Orthomotion
Orthopedic · 133d