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
137017–137040 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 29, 1988
ASTHMAKIT
K874047 · CAF
Dhd Medical Products Div. Diemolding...
Anesthesiology · 147d
Cleared Feb 29, 1988
SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT
K874450 · BTO
Surgitech C/O Collier, Shannon, Rill...
Anesthesiology · 123d
Cleared Feb 29, 1988
RESUSCITATOR
K874567 · BTM
American Medical Technology, Inc.
Anesthesiology · 116d
Cleared Feb 29, 1988
GUARDIAN, EEG BRAIN MONITORING SYSTEM
K874733 · OLT
Tracor Northern, Inc.
Neurology · 103d
Cleared Feb 29, 1988
BIOSURGE MODEL ILVC-1
K875016 · DWS
Biosurge, Inc.
Cardiovascular · 87d
Cleared Feb 29, 1988
SCIMED INFLATION DEVICE, MODEL SM 2000
K875064 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 82d
Cleared Feb 29, 1988
BREATHE-FREE
K875073 · BYE
Cincinnati Medical Technologies, Inc.
Anesthesiology · 82d
Cleared Feb 29, 1988
AIR VENT LINE CAT. NO. AVL-36
K875080 · DTM
American Omni Medical, Inc.
Cardiovascular · 82d
Cleared Feb 29, 1988
AUTO SUTURE DISPOSABLE APPROXIMATING CLAMP*
K875090 · DXC
United States Surgical, A Division of...
Cardiovascular · 82d
Cleared Feb 29, 1988
ORALIN TLC LIGHT CURED PIT AND FISSURE SEALANT
K875091 · EBC
Mission White Dental, Inc.
Dental · 81d
Cleared Feb 29, 1988
ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE
K875094 · KRJ
Pall Biomedical Products Co.
Cardiovascular · 81d
Cleared Feb 29, 1988
PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE
K875095 · JOD
Pall Biomedical Products Co.
Cardiovascular · 81d
Cleared Feb 29, 1988
CIBA CORNING BALANCED HEPARIN FOR CA++
K875117 · CBT
Ciba Corning Diagnostics Corp.
Anesthesiology · 76d
Cleared Feb 29, 1988
PHASE II
K875142 · DYH
Reliance Orthodontic Products, Inc.
Dental · 76d
Cleared Feb 29, 1988
NON-INVASIVE BLOOD PRESSURE MODULE
K875265 · DXN
Ppg Industries, Inc.
Cardiovascular · 69d
Cleared Feb 29, 1988
HI FLOW PORTABLE LIQUID OXYGEN UNIT
K875352 · BYJ
Minnesota Valley Engineering, Inc.
Anesthesiology · 60d
Cleared Feb 29, 1988
EDEC 60R
K880050 · IZO
Electromed Intl., Ltd.
Radiology · 54d
Cleared Feb 29, 1988
VAN-TEC ENDOPYELOTOMY KNIFE
K880094 · EMF
Van-Tec, Inc.
General & Plastic Surgery · 48d
Cleared Feb 29, 1988
LIBERATOR 53/STROLLER 50
K880101 · BYJ
Minnesota Valley Engineering, Inc.
Anesthesiology · 48d
Cleared Feb 29, 1988
CAL/RAD UPGRADE MODEL 1030
K880272 · KPT
Sun Nuclear Corp.
Radiology · 39d
Cleared Feb 29, 1988
TYPE 316L STAINLESS STEEL WIRE
K880309 · JDQ
Winn Hirsch & Assoc.
Orthopedic · 35d
Cleared Feb 29, 1988
PREFILLED WATER FOR IRRIGATION USP
K880316 · BTO
Automatic Liquid Packaging, Inc.
Anesthesiology · 34d
Cleared Feb 29, 1988
PREFILLED SODIUM CHLORIDE SOLUTION FOR IRRIGA. USP
K880317 · BTO
Automatic Liquid Packaging, Inc.
Anesthesiology · 34d
Cleared Feb 29, 1988
FIRST RESPONSE PEDIATRIC EMERGENCY RESUSCITATOR
K880394 · BTM
Intertech/Ohio
Anesthesiology · 31d