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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68425–68448 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 2004
POWERLITE 600 EX SYSTEM
K033933 · GEX
Preswede AB
General & Plastic Surgery · 88d
Cleared Mar 16, 2004
SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
K034012 · GXI
Smith & Nephew, Inc.
Neurology · 83d
Cleared Mar 16, 2004
PLV CONTINUUM VENTILATOR, MODEL P2000
K034032 · NOU
Respironics California, Inc.
Anesthesiology · 78d
Cleared Mar 16, 2004
CORRESTORE PATCH SYSTEM
K040162 · DXZ
Somanetics Corp.
Cardiovascular · 50d
Cleared Mar 16, 2004
VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER
K040492 · MSD
Boston Scientific Corp
Gastroenterology & Urology · 19d
Cleared Mar 16, 2004
ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE,...
K040503 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 18d
Cleared Mar 16, 2004
ZILVER 635 BILIARY STENT
K040505 · FGE
Cook, Inc.
Gastroenterology & Urology · 18d
Cleared Mar 16, 2004
LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS
K040550 · FGE
Orbus Medical Technologies
Gastroenterology & Urology · 14d
Cleared Mar 15, 2004
RESTFUL NIGHTS, IST-APPLIANCE
K021569 · LRK
Ottawa Dental Laboratory
Dental · 671d
Cleared Mar 15, 2004
APEX NRG
K032743 · LQY
Medicnrg , Ltd.
Dental · 193d
Cleared Mar 15, 2004
SERRALAPG
K033762 · GAM
Serral, S.A. DE C.V.
General & Plastic Surgery · 104d
Cleared Mar 15, 2004
BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES
K034052 · LZA
Latexx Manufacturing Sdn.Bhd.
General Hospital · 76d
Cleared Mar 15, 2004
ANSPACH ADVANCED MICRO SAW ATTACHMENTS
K040076 · HBE
The Anspach Effort, Inc.
Neurology · 61d
Cleared Mar 15, 2004
ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS
K040286 · DXQ
Ethox Corp.
Cardiovascular · 38d
Cleared Mar 15, 2004
ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS
K040298 · DXT
Acist Medical Systems, Inc.
Cardiovascular · 35d
Cleared Mar 15, 2004
VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS...
K040355 · DTR
Gish Biomedical, Inc.
Cardiovascular · 32d
Cleared Mar 15, 2004
FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL SUTURE
K040472 · GAT
Teleflex Medical
General & Plastic Surgery · 20d
Cleared Mar 15, 2004
COLTOLUX LED CURING LIGHT
K040551 · EBZ
Coltene/Whaledent, Inc.
Dental · 13d
Cleared Mar 12, 2004
INVACARE POLARIS EX CPAP, MODEL ISP3000
K031064 · BZD
Invacare Corp.
Anesthesiology · 344d
Cleared Mar 12, 2004
ENDOFLEX TRACHEAL TUBE
K031794 · BTR
Merlyn Associates, Inc.
Anesthesiology · 276d
Cleared Mar 12, 2004
DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL...
K032936 · JIX
Stanbio Laboratory
Chemistry · 172d
Cleared Mar 12, 2004
RFS VACUUM GAUGE SCAVENGING CIRCUIT
K033503 · CBN
Accutron, Inc.
Anesthesiology · 128d
Cleared Mar 12, 2004
IMAGE MANAGEMENT SYSTEM
K033870 · HEX
Welch Allyn, Inc.
Obstetrics & Gynecology · 91d
Cleared Mar 12, 2004
SPECTRUM MODULAR SYSTEM
K033893 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 87d