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

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176,076 results
151705–151728 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 1984
SHILEY CORONARY CARDIOPLEGIA ADAPTOR
K843542 · DWF
Shiley, Inc.
Cardiovascular · 41d
Cleared Oct 18, 1984
HOLLOW FIBER DIALYZER
K843632 · KOC
Travenol Laboratories, S.A.
Gastroenterology & Urology · 31d
Cleared Oct 18, 1984
SINGLE WALL INTRODUCER NEEDLE
K843719 · DYB
Ocean Medical Products, Ltd.
Cardiovascular · 24d
Cleared Oct 18, 1984
NAMIC ADB ANGIOGRAPHIC DUMP BAG
K843726 · DQO
North American Instrument Corp.
Cardiovascular · 24d
Cleared Oct 18, 1984
VAPOR-PHASE HUMIDIFIER SYS-ADVANCED
K843932 · BTT
Inspiron Corp.
Anesthesiology · 13d
Cleared Oct 18, 1984
OHMEDA ANESTHESIA RECORD KEEPER
K844012 · BSZ
Ohmeda Medical
Anesthesiology · 6d
Cleared Oct 17, 1984
ENZYGNOST ROTAVIRUS AG
K841243 · LIQ
Behring Diagnostics, Inc.
Immunology · 208d
Cleared Oct 17, 1984
ASTRA 2, ASTRA 3, 4 & 6
K842394 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 120d
Cleared Oct 17, 1984
COBAS-FIBRO
K842717 · JPA
Roche Diagnostic Systems, Inc.
Hematology · 96d
Cleared Oct 17, 1984
TOXOPLASMA GONDII IGM EIA TEST KIT
K842797 · LGD
Labsystems, Inc.
Microbiology · 92d
Cleared Oct 17, 1984
ANALOX LM3 MICRO-STAT ANALYSER
K843082 · JJE
Analox Instruments , Ltd.
Chemistry · 72d
Cleared Oct 17, 1984
DACOS PLUS LYTES OPTION
K843239 · CEM
Coulter Electronics, Inc.
Pathology · 56d
Cleared Oct 17, 1984
MEDTRONIC 5984-5984LP-5985
K843837 · DXY
Medtronic Vascular
Cardiovascular · 16d
Cleared Oct 17, 1984
ULTRACLONE ECL-01-900 CELL LINE
K843862 · KIT
Earl-Clay Laboratories, Inc.
Pathology · 15d
Cleared Oct 17, 1984
ULTRACLONE ECL-01-1300 CELL LINE
K843863 · KIT
Earl-Clay Laboratories, Inc.
Pathology · 15d
Cleared Oct 17, 1984
ULTRACLONE ECL-01-1400 CELL LINE
K843864 · KIT
Earl-Clay Laboratories, Inc.
Pathology · 15d
Cleared Oct 17, 1984
DOUMENT TM LINEARITY TEST STANDARDS
K843947 · JIX
Casco Standards
Chemistry · 8d
Cleared Oct 16, 1984
TETRAFLEX INTEGRALLY SUPPORTED PTFE
K831822 · DSY
Shiley, Inc.
Cardiovascular · 497d
Cleared Oct 16, 1984
EXTENSION SET W/INJECTION SITE
K842984 · FPA
Med Fusion Systems, Inc.
General Hospital · 78d
Cleared Oct 16, 1984
UNIFLEX DANNINGER
K843309 · BXB
Buckman Co., Inc.
Physical Medicine · 54d
Cleared Oct 16, 1984
EMPTY SOLUTION TRANSFER CONTAINER 1000
K843523 · KPE
Polymer Technology Corp.
General Hospital · 39d
Cleared Oct 16, 1984
PNEUMOSCREEN
K843849 · BZC
Erich Jaeger, Inc.
Anesthesiology · 15d
Cleared Oct 15, 1984
PERCUTANEOUS CRICOTHYROIDOTOMY
K822440 · BTO
Frederic J. Toye, M.D.
Anesthesiology · 794d
Cleared Oct 15, 1984
CARDIO METRICS CARDIOTOMY RESERVOIR
K841958 · JOD
Sterile Design, Inc.
Cardiovascular · 154d