Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
70081–70104 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 17, 2004
VECTORVISION CRANIAL/ENT
K023651 · HAW
Brainlab AG
Neurology · 475d
Cleared Feb 17, 2004
ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST...
K032903 · DIO
ACON Laboratories, Inc.
Toxicology · 153d
Cleared Feb 17, 2004
PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000
K032958 · LNS
United Medical Systems, Inc.
Gastroenterology & Urology · 148d
Cleared Feb 17, 2004
ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXYCODONE TEST...
K033047 · DJG
ACON Laboratories, Inc.
Toxicology · 141d
Cleared Feb 17, 2004
ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE
K033768 · ILY
Altus Medical, Inc.
Physical Medicine · 76d
Cleared Feb 17, 2004
WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM
K033909 · FGE
Abbott Laboratories
Gastroenterology & Urology · 62d
Cleared Feb 17, 2004
QLAB QUANTIFICATION SOFTWARE
K040227 · LLZ
Philips Ultrasound
Radiology · 15d
Cleared Feb 17, 2004
SUPRAFLOW CONSOLE
K040239 · BTA
Neomedix Corp.
General & Plastic Surgery · 15d
Cleared Feb 17, 2004
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
K040248 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 14d
Cleared Feb 13, 2004
INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
K031745 · BZD
Sensor Medics Corp.
Anesthesiology · 253d
Cleared Feb 13, 2004
ECHO SOUNDER EX-101EX 8 MHZ
K031931 · DPW
Koven Technology, Inc.
Cardiovascular · 235d
Cleared Feb 13, 2004
MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
K032619 · HCG
Surgica Corp.
Neurology · 171d
Cleared Feb 13, 2004
THE ULTRA SYSTEM SP
K032813 · KCT
Promedica, Inc.
General Hospital · 157d
Cleared Feb 13, 2004
NOVOSCI READY SYSTEM, MODEL RS-200
K033270 · KFM
Novosci Corp.
Cardiovascular · 126d
Cleared Feb 13, 2004
WFSI'S REPROCESSED COMPRESSION SLEEVE DEVICES
K033615 · JOW
Wheaton Franciscan Services Inc.,...
Cardiovascular · 88d
Cleared Feb 13, 2004
PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER
K033715 · DQA
Philips Medical Systems, Inc.
Anesthesiology · 79d
Cleared Feb 13, 2004
VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT
K033721 · FMF
Vascular Solutions, Inc.
General Hospital · 79d
Cleared Feb 13, 2004
EIUS UNICOMPARTMENTAL KNEE SYSTEM
K033769 · HSX
Howmedica Osteonics Corp.
Orthopedic · 72d
Cleared Feb 13, 2004
BAYER SPECIFIC PROTEIN REFERENCE SERUM
K033791 · JIX
Bayer Healthcare, LLC
Chemistry · 71d
Cleared Feb 13, 2004
TITANIUM TOGGLE BUTTON(S)
K033838 · MBI
Biomet Manufacturing, Inc.
Orthopedic · 65d
Cleared Feb 13, 2004
ELECSYS C-PEPTIDE CALSET
K033873 · JIX
Roche Diagnostics Corp.
Toxicology · 60d
Cleared Feb 13, 2004
OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED...
K033883 · JWH
Exactech, Inc.
Orthopedic · 60d
Cleared Feb 13, 2004
HEMOSIL FACTOR VIII DEFICIENT PLASMA
K034007 · GJT
Instrumentation Laboratory CO
Hematology · 51d
Cleared Feb 13, 2004
MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055
K034036 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 46d