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
23857–23880 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 15, 2018
Nexcomp
K181689 · EBF
Meta Biomed Co., Ltd.
Dental · 142d
Cleared Nov 15, 2018
SITZMARKS
K181750 · FFX
Konsyl Pharmaceuticals
Gastroenterology & Urology · 136d
Cleared Nov 15, 2018
IntelliVue Multi-Measurement Module MMX
K181831 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 129d
Cleared Nov 15, 2018
Reprocessed Marinr Diagnostic EP Catheter
K181897 · NLH
Innovative Health, LLC
Cardiovascular · 122d
Cleared Nov 15, 2018
Voluson E6, Voluson E8, Voluson E10
K181985 · IYN
Ge Healthcare
Radiology · 113d
Cleared Nov 15, 2018
CardioBand ECG Event Recorder
K181998 · DPS
Samsung Strategy and Innovation...
Cardiovascular · 112d
Cleared Nov 15, 2018
YUKON OCT Spinal System
K182182 · NKG
K2m
Orthopedic · 94d
Cleared Nov 15, 2018
CanGaroo Neuro Envelope (small)
K182255 · FTM
Aziyo Biologics, Inc.
General & Plastic Surgery · 87d
Cleared Nov 15, 2018
Nitrile Glove Powder Free Black
K182528 · LZA
Haining Medical Products Co., Ltd.
General Hospital · 62d
Cleared Nov 15, 2018
PathLoc-L MIS Spinal System
K183117 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 6d
Cleared Nov 14, 2018
Miracu
K172602 · NEW
Feeltech Co., Ltd.
General & Plastic Surgery · 441d
Cleared Nov 14, 2018
Apoller Flow Light Cure Flowable Composite
K180463 · EBF
Greenway Yw, LLC
Dental · 266d
Cleared Nov 14, 2018
Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs
K181090 · IOR
Invacare Corporation
Physical Medicine · 203d
Cleared Nov 14, 2018
SporView Rapid Read Biological Indicator SteamPlus Test Pack
K181434 · FRC
Crosstex/Spsmedical, A Division of...
General Hospital · 166d
Cleared Nov 14, 2018
HPM-6000UF
K181497 · KPI
BTL Industries, Inc.
Gastroenterology & Urology · 160d
Cleared Nov 14, 2018
Velofix TLIF Cage
K181829 · MAX
U&I Corporation
Orthopedic · 128d
Cleared Nov 14, 2018
Inversa Implants
K181850 · DZE
Southern Implants (Pty), Ltd.
Dental · 126d
Cleared Nov 14, 2018
VivaSight-DL System
K181886 · CBI
Etview , Ltd.
Anesthesiology · 124d
Cleared Nov 14, 2018
ostaPek Interbody Fusion Cages
K181963 · MAX
Coligne AG
Orthopedic · 114d
Cleared Nov 14, 2018
React 71 Catheter
K182097 · DQY
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 103d
Cleared Nov 14, 2018
Riptide Aspiration System (React 71 Catheter)
K182101 · NRY
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 103d
Cleared Nov 14, 2018
JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored...
K182105 · NUC
United Consortium
Obstetrics & Gynecology · 103d
Cleared Nov 14, 2018
Wearable Device
K182543 · MSX
Snap40, Ltd.
Cardiovascular · 58d
Cleared Nov 14, 2018
Z6 Diagnostic Ultrasound System
K182603 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 54d