FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
17641–17664 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 2021
APOLLO Anterior Cervical Plate (ACP) System
K210325 · KWQ
Aurora Spine, Inc.
Orthopedic · 47d
Cleared Mar 23, 2021
7D Surgical System - Drill Guide
K210555 · OLO
7D Surgical, Inc.
Orthopedic · 26d
Cleared Mar 23, 2021
DIOnavi-Denture02
K210828 · EBI
Dio Corporation
Dental · 4d
Cleared Mar 22, 2021
Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008,...
K202009 · FLL
Shenzhen Juzhong Technology Co., Ltd.
General Hospital · 244d
Cleared Mar 22, 2021
EZ-IO Intraosseous Vascular Access System
K202492 · FMI
Teleflex Medical
General Hospital · 203d
Cleared Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit
K203289 · LSR
Gold Standard Diagnostics
Microbiology · 133d
Cleared Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
K203292 · LSR
Gold Standard Diagnostics
Microbiology · 133d
Cleared Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
K203295 · LSR
Gold Standard Diagnostics
Microbiology · 133d
Cleared Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
K203296 · LSR
Gold Standard Diagnostics
Microbiology · 133d
Cleared Mar 22, 2021
Capture-CMV
K203612 · LJO
Immucor, Inc.
Microbiology · 102d
Cleared Mar 22, 2021
Spark Clear Aligner System
K203737 · NXC
Ormco Corporation
Dental · 90d
Cleared Mar 21, 2021
Movement and Compressions System (the MAC System)
K203052 · JOW
Recovery Force, LLC
Cardiovascular · 165d
Cleared Mar 19, 2021
ZIDA Wearable Neuromodulation System
K192731 · NAM
Exodus Innovations
Gastroenterology & Urology · 539d
Cleared Mar 19, 2021
Sovereign America Surgical Face Mask
K201095 · FXX
Homtex, Inc.
General Hospital · 329d
Cleared Mar 19, 2021
Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis...
K202081 · LZA
Shen Wei (Usa), Inc.
General Hospital · 235d
Cleared Mar 19, 2021
Invacare AVIVA Storm RX Power Chair
K202379 · ITI
Invacare Corporation
Physical Medicine · 211d
Cleared Mar 19, 2021
Disposable Medical Face Mask
K202628 · FXX
Qinghai Zhong Dao Win-Win Medical...
General Hospital · 189d
Cleared Mar 19, 2021
LightWalker Laser System Family
K202985 · GEX
Fotona D.O.O.
General & Plastic Surgery · 170d
Cleared Mar 19, 2021
SensorX
K203116 · MUH
Durr Dental SE
Radiology · 154d
Cleared Mar 19, 2021
VBrain
K203235 · QKB
Vysioneer, Inc.
Radiology · 136d
Cleared Mar 19, 2021
Patient Examination Gloves
K203593 · LZA
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 100d
Cleared Mar 19, 2021
BonOs HV, BonOs MV, BonOs LV
K210120 · LOD
Osartis GmbH
Orthopedic · 59d
Cleared Mar 19, 2021
BonOs HV Genta, BonOs MV Genta, BonOs LV Genta
K210125 · LOD
Osartis GmbH
Orthopedic · 59d
Cleared Mar 19, 2021
SPINEART Navigation Instrument System
K210472 · OLO
Spineart
Orthopedic · 30d