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
13633–13656 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 06, 2022
Quantum Heater-Cooler
K212657 · DWC
Spectrum Medical , Ltd.
Cardiovascular · 256d
Cleared May 06, 2022
TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)
K213788 · NUH
Dongguan Bohuikang Technology Co.,Ltd
Neurology · 151d
Cleared May 06, 2022
Disposable EEG cable
K213884 · GXY
Shenzhen Changke Connect Electronics...
Neurology · 144d
Cleared May 06, 2022
WAVi SCAN EEG System and Accessories
K213900 · GWQ
Wavi Co.
Neurology · 143d
Cleared May 06, 2022
PISCES-SA Standalone ALIF Interbody System
K213935 · OVD
Osseus Fusion Systems
Orthopedic · 141d
Cleared May 06, 2022
KEOPS Balance Analyzer 3D
K213975 · LLZ
S.M.A.I.O
Radiology · 137d
Cleared May 06, 2022
Masimo O3 Regional Oximeter System
K214072 · MUD
Masimo Corporation
General & Plastic Surgery · 130d
Cleared May 06, 2022
Medline Orbis Chemo Surgical Gown
K214108 · FYA
Medline Industries, LP
General Hospital · 128d
Cleared May 06, 2022
Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia...
K220110 · DTR
Qura S.R.L
Cardiovascular · 113d
Cleared May 06, 2022
HM70 EVO Diagnostic Ultrasound System
K220269 · IYN
Samsung Medison Co., Ltd.
Radiology · 95d
Cleared May 06, 2022
Astroglide Glycerin & Paraben Free
K220653 · NUC
Biofilm, Inc.
Obstetrics & Gynecology · 60d
Cleared May 06, 2022
NewTom 7G
K220664 · JAK
Cefla S.C.
Radiology · 60d
Cleared May 06, 2022
Vatech Clismile
K220689 · NJM
Rayence Co., Ltd.
Dental · 58d
Cleared May 06, 2022
Invu by Nuvo
K221046 · LQK
Nuvo- Group , Ltd.
Obstetrics & Gynecology · 28d
Cleared May 05, 2022
PosiSep EAR Fragmentable Ear Dressing
K210411 · NHB
Hemostasis, LLC
Ear, Nose, Throat · 448d
Cleared May 05, 2022
Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1,...
K210565 · FLL
Alicn Medical (Shenzhen), Inc.
General Hospital · 434d
Cleared May 05, 2022
NAVIRFA Scope
K211529 · IYO
Navifus Corporation
Radiology · 353d
Cleared May 05, 2022
Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618
K212346 · FLL
Shenzhen Pango Medical Electronics...
General Hospital · 281d
Cleared May 05, 2022
Neuromuscular Transmission Monitor TOF3D
K212434 · KOI
MIPM Mammendorfer Institut f?r Physik...
Anesthesiology · 274d
Cleared May 05, 2022
Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set
K212756 · OLO
Medos International SARL
Orthopedic · 247d
Cleared May 05, 2022
HandPICO
K220041 · GEX
Vydence Medical Industria E Comercio...
General & Plastic Surgery · 120d
Cleared May 05, 2022
17HQ901G-B
K220559 · MQB
Lg Electronics.Inc
Radiology · 66d
Cleared May 05, 2022
HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx
K220685 · NFT
Qingdao Hightop Biotech Co., Ltd.
Toxicology · 58d
Cleared May 05, 2022
LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension
K220691 · DQY
Seigla Medical, Inc.
Cardiovascular · 57d