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
9313–9336 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 07, 2023
Pounce™ Sheath
K231828 · DYB
Surmodics,Inc.
Cardiovascular · 78d
Cleared Sep 07, 2023
IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9
K231800 · OHT
Shenzhen Qianyu Technology Co., Ltd.
General & Plastic Surgery · 79d
Cleared Sep 07, 2023
Gradual Dental Zirconia Blank
K231687 · EIH
Liaoning Upcera Co., Ltd.
Dental · 90d
Cleared Sep 07, 2023
Digital Blood Pressure Monitor WBP Series
K231542 · DXN
Weony (Shenzhen) Technology Co., Ltd.
Cardiovascular · 100d
Cleared Sep 07, 2023
CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
K231207 · DQK
Biosense Webster, Inc.
Cardiovascular · 133d
Cleared Sep 07, 2023
Arm Blood Pressure Monitor
K230649 · DXN
Alicn Medical (Shenzhen), Inc.
Cardiovascular · 182d
Cleared Sep 07, 2023
Signum opaque F
K230644 · EBF
Kulzer, LLC
Dental · 183d
Cleared Sep 07, 2023
SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate,...
K230049 · HIS
Ttk Healthcare Limited
Obstetrics & Gynecology · 244d
Cleared Sep 07, 2023
AeroDVx Arm System
K222823 · JOW
Sun Scientific, Inc.
Cardiovascular · 353d
Cleared Sep 07, 2023
Radio Frequency Plasma Surgical Systems
K221743 · GEI
Jiangsu Bonss Medical Technology Co.,...
Ear, Nose, Throat · 449d
Cleared Sep 06, 2023
MAGNETOM Viato.Mobile
K232482 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 21d
Cleared Sep 06, 2023
IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012,...
K231717 · OHT
Foshan Jindi Electric Appliance Co.,...
General & Plastic Surgery · 85d
Cleared Sep 06, 2023
IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
K230824 · LPL
Art Optical Contact Lens, Inc.
Ophthalmic · 166d
Cleared Sep 06, 2023
Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic...
K230127 · FGE
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 232d
Cleared Sep 06, 2023
HI-EMT MAGSHAPE
K230024 · NGX
Beijing Sano Laser S&T Development...
Physical Medicine · 245d
Cleared Sep 06, 2023
Phoenix ICON, Phoenix ICON GO
K223575 · HKI
Neolight, LLC
Ophthalmic · 280d
Cleared Sep 05, 2023
Polibond
K232691 · EBI
Zirkonzahn Srl
Dental · 4d
Cleared Sep 05, 2023
Promaxo MRI System II
K232361 · LNH
Promaxo, Inc.
Radiology · 29d
Cleared Sep 05, 2023
Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
K231819 · HWC
Innovate Orthopaedics Limited
Orthopedic · 76d
Cleared Sep 05, 2023
ICHOR 14F Embolectomy System
K230743 · QEW
Ichor
Cardiovascular · 173d
Cleared Sep 05, 2023
F&P 820 Humidification System
K223684 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 271d
Cleared Sep 05, 2023
BCR-ABL1 (p210) % IS Kit (Digital PCR Method)
K221869 · OYX
Suzhou Sniper Medical Technologies...
Medical Genetics · 434d
Cleared Sep 05, 2023
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
K221197 · CEW
Ortho-Clinical Diagnostics
Chemistry · 498d
Cleared Sep 05, 2023
Ki Power Tilt System
K201869 · ITI
Ki Mobility, LLC
Physical Medicine · 1155d