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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
145537–145560 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 1986
CARDISUNY 501 A
K852829 · DPS
Atrix
Cardiovascular · 238d
Cleared Feb 26, 1986
NEOCARE MODEL 800 INFANT RADIANT WARMER
K853926 · FMT
Draeger Medical, Inc.
General Hospital · 155d
Cleared Feb 26, 1986
OSCOR MEDICAL UNIPOLAR PERMANENT PACING LEAD-CONNE
K854128 · DTB
Oscor Medical Corp.
Cardiovascular · 140d
Cleared Feb 26, 1986
HEATER PROBE-ACCESS FOR MEDPACIFIC LD5000 LASER -
K854500 · DPW
Medpacific Corp.
Cardiovascular · 106d
Cleared Feb 26, 1986
COATEST PLASMINOGEN
K854572 · DDX
Kabivitrum, Inc.
Hematology · 104d
Cleared Feb 26, 1986
MODIFIED CORDIS PTCA GUIDING CATHETERS
K854576 · DQO
Cordis Corp.
Cardiovascular · 105d
Cleared Feb 26, 1986
TRAVELPAK MODEL DC-202
K854748 · CAW
Travomed, Inc.
Anesthesiology · 92d
Cleared Feb 26, 1986
CPR SLIDE EIKEN
K854819 · DCN
Syn-Kit, Inc.
Immunology · 85d
Cleared Feb 26, 1986
AMI E-Z-PACE ELECTODE
K854924 · DRO
A.M.I. Corp.
Cardiovascular · 78d
Cleared Feb 26, 1986
QUANTIMETRIC PLUS LAMBDA REAGENT KIT
K855007 · DEH
Kallestad Laboratories, Inc.
Immunology · 72d
Cleared Feb 26, 1986
QUANTIMETRIC PLUS KAPPA REAGENT KIT
K855008 · DFH
Kallestad Laboratories, Inc.
Immunology · 72d
Cleared Feb 26, 1986
QUANTIMETRIC PLUS IGA REAGENT KIT
K855009 · CZP
Kallestad Laboratories, Inc.
Immunology · 72d
Cleared Feb 26, 1986
QUANTIMETRIC PLUS C3 REAGENT KIT
K855011 · CZN
Kallestad Laboratories, Inc.
Immunology · 72d
Cleared Feb 26, 1986
QUANTIMETRIC PLUS C4 REAGENT KIT
K855012 · DBI
Kallestad Laboratories, Inc.
Immunology · 72d
Cleared Feb 26, 1986
QUANTIMETRIC PLUS SUPPORT PACK
K855013 · DEH
Kallestad Laboratories, Inc.
Immunology · 72d
Cleared Feb 26, 1986
MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR
K855049 · DTP
Scimed Life Systems, Inc.
Cardiovascular · 71d
Cleared Feb 26, 1986
LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS)
K855057 · DCN
Behring Diagnostics, Inc.
Immunology · 70d
Cleared Feb 26, 1986
SWANK ARTERIAL LINE BLOOD FILTER HF6000
K855066 · DTM
Cobe Laboratories, Inc.
Cardiovascular · 70d
Cleared Feb 26, 1986
SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100
K855067 · JOD
Cobe Laboratories, Inc.
Cardiovascular · 70d
Cleared Feb 26, 1986
S.L.T. CONTACT LASER SYSTEM
K855100 · LNK
Surgical Laser Technologies, Inc.
Gastroenterology & Urology · 65d
Cleared Feb 26, 1986
CORDIS CATHETER SHEATH INTRODUCERS,STERI-SLEEVES
K855126 · DYB
Cordis Corp.
Cardiovascular · 65d
Cleared Feb 26, 1986
FLEXON TEMPORARY CARDIAC CONDUCTIVE MULTIFILAMENT
K855139 · LDF
Davis & Geck, Inc.
Cardiovascular · 65d
Cleared Feb 26, 1986
MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR
K855145 · DRS
Gould, Inc.
Cardiovascular · 64d
Cleared Feb 26, 1986
BLOOD COLLECTING NEEDLE
K855248 · FMI
Churchill Corp.
General Hospital · 77d