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
6409–6432 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 2024
DELTAWAVE Nasal Pillows System
K233415 · BZD
Remsleep Holdings
Anesthesiology · 266d
Cleared Jul 02, 2024
FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT*...
K232824 · FXX
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 293d
Cleared Jul 01, 2024
Single-use Video Ureterorenoscope (SVU-220US)
K241639 · FGB
Huger Medical Instrument Co., Ltd.
Gastroenterology & Urology · 24d
Cleared Jul 01, 2024
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with...
K241598 · FGB
Boston Scientific Corporation
Gastroenterology & Urology · 27d
Cleared Jul 01, 2024
Electric nasal aspirator (HTD2601US)
K241202 · BTA
Hetaida Technology Co., Ltd.
Ear, Nose, Throat · 62d
Cleared Jul 01, 2024
BioSonic US200 Ultrasonic Scaler (60034537)
K240801 · ELC
Dent4you AG
Dental · 98d
Cleared Jul 01, 2024
Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m)...
K240572 · GEI
Covidien, LLC
General & Plastic Surgery · 123d
Cleared Jul 01, 2024
Wearable Breast Pump (Model S32)
K240536 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 126d
Cleared Jul 01, 2024
Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
K240477 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 132d
Cleared Jul 01, 2024
Hyper Insight - ICH
K240353 · QAS
Sk, Inc.
Radiology · 147d
Cleared Jul 01, 2024
SPECTRALIS HRA+OCT and variants
K240221 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 157d
Cleared Jul 01, 2024
Profound Matrix
K240070 · GEI
Candela Corporation
General & Plastic Surgery · 174d
Cleared Jul 01, 2024
StarFormer
K234061 · KPI
Fotona D.O.O.
Gastroenterology & Urology · 192d
Cleared Jul 01, 2024
cNeuro cDAT
K233908 · LLZ
Combinostics OY
Radiology · 202d
Cleared Jul 01, 2024
Cryo-straw (Type I, Type III)
K233477 · MQL
Shandong Wego Ruisheng Medical Device...
Obstetrics & Gynecology · 249d
Cleared Jul 01, 2024
Pulse Oximeter (AOJ-70A)
K232989 · DQA
Shenzhen AOJ Medical Technology Co.,...
Anesthesiology · 283d
Cleared Jul 01, 2024
FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops,...
K232777 · FXX
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 294d
Cleared Jul 01, 2024
Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters
K231015 · NLI
Innovative Health, LLC
Cardiovascular · 448d
Cleared Jun 28, 2024
nordicMEDiVA
K241608 · LLZ
Nordicneurolab AS
Radiology · 24d
Cleared Jun 28, 2024
NUVISION™ Ultrasound Catheter
K241540 · OBJ
Biosense Webster, Inc.
Cardiovascular · 28d
Cleared Jun 28, 2024
Lavieen
K241406 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 42d
Cleared Jun 28, 2024
Hello,eyes® BIO Plug
K241229 · LZU
Bio Optics Co., Ltd.
Ophthalmic · 57d
Cleared Jun 28, 2024
TopCEM-Veneer Light Cure Veneer Cement
K241204 · EMA
Rizhao Huge Biomaterials Company, Ltd.
Dental · 59d
Cleared Jun 28, 2024
Electric Wheelchair (YFWB-63)
K241154 · ITI
If Health (Xiamen) Intelligent...
Physical Medicine · 63d