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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
73969–73992 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 2002
\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW...
K022536 · KOC
Fresenius Medical Care
Gastroenterology & Urology · 90d
Cleared Oct 30, 2002
NEWDEAL K WIRE
K022599 · HTY
New Deal, S.A.
Orthopedic · 86d
Cleared Oct 30, 2002
NEW OUTLINE
K023079 · EBG
Anaxdent GmbH
Dental · 44d
Cleared Oct 30, 2002
PHILIPS DIGITAL IMAGING OPTION RELEASE 1
K023440 · LLZ
Philips Medical Systems
Radiology · 15d
Cleared Oct 30, 2002
PHILIPS MULTIDIAGNOST ELEVA
K023441 · IZI
Philips Medical Systems
Radiology · 15d
Cleared Oct 29, 2002
SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001
K020641 · BZD
Worldwide Medical Technologies, LLC
Anesthesiology · 244d
Cleared Oct 29, 2002
TRAXX ELECTRIC WHEELCHAIR
K022194 · ITI
Crossroads Distribution Company, LLC
Physical Medicine · 116d
Cleared Oct 29, 2002
CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR
K022615 · JDK
Centerpulse Spine-Tech, Inc.
Orthopedic · 83d
Cleared Oct 29, 2002
MOISTURESTAY (REVLON)
K022626 · IMC
Raymond Industrial, Ltd.
Physical Medicine · 83d
Cleared Oct 29, 2002
EXPORT ASPIRATION CATHETER
K023303 · NFA
Medtronic Vascular
Cardiovascular · 26d
Cleared Oct 29, 2002
1CC FUTURA SAFETY SYRINGE
K023323 · MEG
Futura Medical Technology
General Hospital · 25d
Cleared Oct 29, 2002
DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP
K023471 · LZG
Disetronic Medical Systems AG
General Hospital · 14d
Cleared Oct 28, 2002
ARTERIA OCCLUSION BALLOON
K021210 · MJN
Arteria Medical Science, Inc.
Cardiovascular · 194d
Cleared Oct 28, 2002
NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT
K021541 · JNB
Perkinelmer Life Sciences
Chemistry · 171d
Cleared Oct 28, 2002
KARATS MULTIPURPOSE SOLUTION
K021635 · LPN
Ciba Vision Corporation
Ophthalmic · 164d
Cleared Oct 28, 2002
ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE
K022589 · LAF
ACON Laboratories, Inc.
Chemistry · 84d
Cleared Oct 28, 2002
IBOND GLUMA INSIDE
K022612 · KLE
Heraeus Kulzer, Inc.
Dental · 83d
Cleared Oct 28, 2002
ELITE MONOPHASE
K022653 · ELW
Zhermack S.P.A.
Dental · 80d
Cleared Oct 28, 2002
MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE...
K022941 · LFR
Abbott Laboratories
Chemistry · 55d
Cleared Oct 28, 2002
PQ1
K023042 · KLE
Ultradent Products, Inc.
Dental · 46d
Cleared Oct 28, 2002
POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (200...
K023262 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 28d
Cleared Oct 28, 2002
HI-TORQUE WHISPER LS
K023300 · DQX
Guidant Corp.
Cardiovascular · 25d
Cleared Oct 28, 2002
ENVIRON-NP DISPOSABLE SYNTHETIC VINYL EXAM GLOVES, POWDERED
K023343 · LYZ
Shanghai Palomar Mountain Industries,...
General Hospital · 21d
Cleared Oct 28, 2002
TRUCATH.IP
K023368 · DFG
Aortech Critical Care , Ltd.
Immunology · 20d