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
33625–33648 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 2015
BioGuard Air/Water Valve, BioGuard Suction Valve
K151345 · ODC
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 98d
Cleared Aug 25, 2015
Nuocande Plastic Manual Wheelchair Model NKD L07
K151797 · IOR
Ningbo Lecount Medical Technology...
Physical Medicine · 54d
Cleared Aug 25, 2015
Retraction Aspirator
K152097 · QEW
Inari Medical
Cardiovascular · 28d
Cleared Aug 24, 2015
LED Curing Light
K150205 · EBZ
Monitex Industrial Co., Ltd.
Dental · 207d
Cleared Aug 24, 2015
Skynector CPAP Mask
K150685 · BZD
Sky Wise Medical Instrument (Shen...
Anesthesiology · 160d
Cleared Aug 24, 2015
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs...
K151343 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 97d
Cleared Aug 21, 2015
BC-3600 Auto Hematology Analyzer
K143348 · GKZ
Mindray Bio-Medical Electronics Co.,...
Hematology · 273d
Cleared Aug 21, 2015
SynePure Wound Cleanser
K143444 · FRO
Synedgen, Inc.
General & Plastic Surgery · 262d
Cleared Aug 21, 2015
Lifelines iEEG
K143487 · OLT
Kvikna Ehf
Neurology · 256d
Cleared Aug 21, 2015
UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal...
K143529 · NUC
Medline Industries, Inc.
Obstetrics & Gynecology · 252d
Cleared Aug 21, 2015
GranOSTM - beta tricalcium phosphate synthetic bone granules
K143692 · MQV
Tcm Associates, Ltd.
Orthopedic · 240d
Cleared Aug 21, 2015
SYNFIX Evolution Secured Spacer System
K150673 · OVD
Synthes USA Products, LLC
Orthopedic · 158d
Cleared Aug 21, 2015
PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory...
K150704 · EMA
Kuraray Noritake Dental, Inc.
Dental · 156d
Cleared Aug 21, 2015
CS 8100SC, CS8100SC Access
K151087 · MUH
Trophy
Radiology · 120d
Cleared Aug 21, 2015
UCP Drug Test Mini Cups
K151213 · DKZ
Ucp Biosciences, Inc.
Toxicology · 107d
Cleared Aug 21, 2015
LightStim for Pain LED Belt
K151333 · ILY
Led Intellectual Properties, LLC
Physical Medicine · 94d
Cleared Aug 21, 2015
Reform Pedicle Screw System
K151422 · NKB
Precision Spine, Inc.
Orthopedic · 85d
Cleared Aug 21, 2015
Capillus82
K151516 · OAP
Capillus, LLC
General & Plastic Surgery · 77d
Cleared Aug 21, 2015
STERISPINE LC CAGE
K151756 · MAX
Safe Orthopaedics
Orthopedic · 53d
Cleared Aug 21, 2015
SALVATION® External Fixation System
K152045 · KTT
Wrightmedicaltechnologyinc
Orthopedic · 29d
Cleared Aug 20, 2015
PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION...
K141017 · OMP
Kci USA, Inc. (Kinetic Concepts, Inc.)
General & Plastic Surgery · 486d
Cleared Aug 20, 2015
OC-Light S FIT
K143325 · KHE
Eiken Chemical Co., Ltd.
Hematology · 273d
Cleared Aug 20, 2015
Natrelle 133 Plus Tissue Expander
K143354 · LCJ
Allergan, Inc.
General & Plastic Surgery · 269d
Cleared Aug 20, 2015
Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T
K143556 · FDA
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 248d