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
12697–12720 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 2022
Pentaflush
K214080 · NGT
Pentaferte Italia S.R.L.
General Hospital · 205d
Cleared Jul 20, 2022
AutoSeg
K220039 · LLZ
Ai Medic, Inc.
Radiology · 196d
Cleared Jul 20, 2022
Biofeedback Nerve and Muscle Stimulator
K220161 · KPI
Shenzhen Konmed Technology Co., Ltd.
Gastroenterology & Urology · 181d
Cleared Jul 20, 2022
Pediatric Nailing Platform Femur
K220679 · HSB
OrthoPediatrics Corp.
Orthopedic · 134d
Cleared Jul 20, 2022
Libby Echo:Prio
K220956 · QIH
Dyad Medical, Inc.
Radiology · 110d
Cleared Jul 20, 2022
TruDi Shaver Blade
K221037 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 104d
Cleared Jul 20, 2022
AF Laser
K221363 · PDZ
ShenB Co., Ltd.
General & Plastic Surgery · 70d
Cleared Jul 20, 2022
Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)
K221512 · MQB
Vieworks Co., Ltd.
Radiology · 57d
Cleared Jul 20, 2022
Vario-Cup System
K221794 · KWY
Waldemar Link GmbH & Co. KG
Orthopedic · 29d
Cleared Jul 19, 2022
Tiche PTA Balloon Dilatation Catheter
K212215 · LIT
Brosmed Medical Co., Ltd.
Cardiovascular · 369d
Cleared Jul 19, 2022
Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular...
K213357 · DXH
Verily Life Sciences, LLC
Cardiovascular · 280d
Cleared Jul 19, 2022
ZEUS System (Zio Watch)
K213409 · DQK
iRhythm Technologies, Inc.
Cardiovascular · 273d
Cleared Jul 19, 2022
MAGIC Flow-Dependent Microcatheter
K213435 · KRA
Balt USA, LLC
Neurology · 270d
Cleared Jul 19, 2022
Joule diVa System
K213761 · GEX
Sciton, Inc
General & Plastic Surgery · 230d
Cleared Jul 19, 2022
Surgical face mask
K220777 · FXX
Hubei Qianjiang Kingphar Medical...
General Hospital · 124d
Cleared Jul 19, 2022
BrainInsight
K220815 · QIH
Hyperfine, Inc.
Radiology · 120d
Cleared Jul 19, 2022
Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy...
K220943 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 110d
Cleared Jul 19, 2022
Beauty LED Mask, Model: KFB265
K221151 · OHS
Hunan Guangye Biotechnology Co., Ltd.
General & Plastic Surgery · 90d
Cleared Jul 19, 2022
ARTIS icono (Ceiling Configuration)
K221516 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 55d
Cleared Jul 19, 2022
Selectra Lead Implantation System
K222037 · DQY
Biotronik, Inc.
Cardiovascular · 8d
Cleared Jul 18, 2022
KLS Martin Individual Patient Solutions
K210731 · JEY
KLS-Martin L.P.
Dental · 494d
Cleared Jul 18, 2022
Planmed Clarity 2D, Planmed Clarify S
K211720 · MUE
Planmed OY
Radiology · 409d
Cleared Jul 18, 2022
OSSIX Breeze
K212509 · NPL
Datum Dental, Ltd.
Dental · 343d
Cleared Jul 18, 2022
Ultrasonic Scalpel System
K212614 · LFL
Surgnova Healthcare Technologies...
General & Plastic Surgery · 334d