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
39385–39408 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 2013
ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK
K131663 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 133d
Cleared Oct 18, 2013
MULTIFUNCTIONAL SERIES
K131859 · ONF
Beijing Honkon Technologies Co., Ltd.
General & Plastic Surgery · 116d
Cleared Oct 18, 2013
PROVOX VEGA PUNCTURE SET
K131947 · EWL
Atos Medical AB
Ear, Nose, Throat · 113d
Cleared Oct 18, 2013
REMSTAR AUTO A-FLEX HT
K131982 · BZD
Respironics, Inc.
Anesthesiology · 112d
Cleared Oct 18, 2013
RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET,...
K132096 · LDJ
Biophor Diagnostics, Inc.
Toxicology · 102d
Cleared Oct 18, 2013
ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY
K132571 · JHY
Roche Diagnostics
Chemistry · 64d
Cleared Oct 18, 2013
DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS
K132947 · KRA
Boston Scientific Corp
Cardiovascular · 29d
Cleared Oct 17, 2013
SAPPHIRE INFUSION PUMP
K123049 · FRN
Q Core Medical , Ltd.
General Hospital · 384d
Cleared Oct 17, 2013
NBM-200MP
K124041 · DQA
Orsense, Ltd.
Anesthesiology · 293d
Cleared Oct 17, 2013
RESPIGUIDE DELIVERY SYSTEM
K130378 · DQY
Respicardia
Cardiovascular · 245d
Cleared Oct 17, 2013
BIOROOT RCS
K130601 · KIF
Novocol, Inc.
Dental · 224d
Cleared Oct 17, 2013
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
K130719 · OGZ
Infraredx, Inc.
Cardiovascular · 213d
Cleared Oct 17, 2013
LEGACY MEDICAL ECO-CHOICE DISPOSABLE BLOOD PRESSURE CUFF
K130942 · DXQ
Legacy Medical, Inc.
Cardiovascular · 196d
Cleared Oct 17, 2013
TRUE SPINAL FIXATION SYSTEM
K130958 · MNI
Innovative Surgical Designs
Orthopedic · 195d
Cleared Oct 17, 2013
FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM
K131013 · NBW
Nova Biomedical Corporation
Chemistry · 189d
Cleared Oct 17, 2013
UNIVATION
K131167 · HRY
Aesculap Implant Systems, LLC
Orthopedic · 176d
Cleared Oct 17, 2013
AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE
K131459 · JDW
Aap Implantate AG
Orthopedic · 150d
Cleared Oct 17, 2013
UNIVERSAL NEURO 3 SYSTEM
K131775 · GWO
Stryker
Neurology · 122d
Cleared Oct 17, 2013
INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550
K131872 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 115d
Cleared Oct 17, 2013
SOMNOLYZER 24X7
K131994 · MNR
Respironics, Inc.
Anesthesiology · 111d
Cleared Oct 17, 2013
TRANSCEND AUTO
K132127 · BZD
Somnetics International, Inc.
Anesthesiology · 99d
Cleared Oct 17, 2013
APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)
K132251 · LSL
Hologic / Gen-Probe Incorporated
Microbiology · 90d
Cleared Oct 17, 2013
GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION
K132272 · NBW
Glooko, Inc.
Chemistry · 87d
Cleared Oct 17, 2013
STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER
K132430 · LIT
Boston Scientific Corp
Cardiovascular · 73d