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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
14209–14232 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 2021
Pulse Oximeter
K210305 · DQA
Dongguan Lingxin Technologies Co., Ltd.
Anesthesiology · 322d
Cleared Dec 22, 2021
Neocis Guidance System (NGS) with Yomi Plan v2.0.1
K210711 · PLV
Neocis, Inc.
Dental · 287d
Cleared Dec 22, 2021
BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle
K210978 · BSP
Becton, Dickinson and Company
Anesthesiology · 265d
Cleared Dec 22, 2021
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with...
K211022 · LZA
Central Medicare Sdn Bhd
General Hospital · 261d
Cleared Dec 22, 2021
Ultrast Gel
K211691 · MUI
Ultrast, Inc.
Radiology · 203d
Cleared Dec 22, 2021
Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310...
K212285 · NUH
Oriental Inspiration Limited
Neurology · 154d
Cleared Dec 22, 2021
EyeBOX (Model EBX-4)
K212310 · QEA
Oculogica, Inc.
Neurology · 152d
Cleared Dec 22, 2021
StealthStation S8 Cranial v2.0
K212397 · HAW
Medtronic Navigation
Neurology · 142d
Cleared Dec 22, 2021
Non Absorbable Surgical Nylon Suture
K212603 · GAR
Shandong Haidike Medical Product Co.,...
General & Plastic Surgery · 127d
Cleared Dec 22, 2021
SleepRight Select-Comfort Dental Guard
K212767 · MQC
Splintek, Inc.
Dental · 113d
Cleared Dec 22, 2021
Glovmaster Nitrile Examination Glove Powder Free
K212914 · LZA
Glovmaster Sdn. Bhd.
General Hospital · 100d
Cleared Dec 22, 2021
Oren LED Perioral Light Therapy System
K213024 · OHS
Shenzhen Kaiyan Medical CO , Ltd.
General & Plastic Surgery · 92d
Cleared Dec 22, 2021
ID-500 iRestore Hair Growth System
K213094 · OAP
Freedom Laser Therapy, Inc.
General & Plastic Surgery · 89d
Cleared Dec 22, 2021
Claritas iPET
K213140 · LLZ
Claritas Healthtech Pte, Ltd.
Radiology · 86d
Cleared Dec 22, 2021
Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors
K213144 · LYZ
Shen Wei (Usa), Inc.
General Hospital · 86d
Cleared Dec 22, 2021
Encore System
K213159 · ORY
Siesta Medical, Inc.
Dental · 85d
Cleared Dec 22, 2021
Sheath, Stopcock Accessory
K213207 · HIH
Olympus Winter & Ibe GmbH
Obstetrics & Gynecology · 84d
Cleared Dec 22, 2021
Diode Laser System GP900A8, Diode Laser System GP900Q8
K213225 · GEX
Shenzhen Gsd Tech Co., Ltd.
General & Plastic Surgery · 84d
Cleared Dec 22, 2021
iSR’obot Mona Lisa 2.0
K213411 · IYO
Biobot Surgical Pte., Ltd.
Radiology · 64d
Cleared Dec 22, 2021
EdgePro
K213428 · NVK
Biolase, Inc.
Dental · 62d
Cleared Dec 22, 2021
Solas OR
K213691 · MWP
Cirdan Imaging, Ltd.
Radiology · 29d
Cleared Dec 21, 2021
Wesper Lab
K203343 · MNR
Wesper, Inc.
Anesthesiology · 403d
Cleared Dec 21, 2021
TRI-matrix Implant Line
K203660 · DZE
Tri Dental Implants Int. AG
Dental · 371d
Cleared Dec 21, 2021
Meticuly Patient-Specific Titanium Mesh Implant
K210099 · GXN
Meticuly Co., Ltd.
Neurology · 341d