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
154753–154776 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 14, 1984
VESSEL DILATOR
K840641
Aries Medical, Inc.
Cardiovascular
Cleared Feb 13, 1984
PILLOW COVER, ANTI-MICROBIAL
K832486 · KME
American Threshold Industries, Inc.
General Hospital · 203d
Cleared Feb 13, 1984
DRAW SHEET, ANTI-MICROBIAL
K832487 · KME
American Threshold Industries, Inc.
General Hospital · 203d
Cleared Feb 13, 1984
RESPIRATION MONITOR
K832999 · FLS
Litton Medical Electronics
Anesthesiology · 179d
Cleared Feb 13, 1984
CLOUTIER II FIBER METAL TOTAL KNEE
K833363 · JWH
Zimmer, Inc.
Orthopedic · 139d
Cleared Feb 13, 1984
IDS RAPID STR SYSTEM
K833654 · JTO
Innovative Diagnostic Systems, Inc.
Microbiology · 116d
Cleared Feb 13, 1984
CHLAMYDIAE ISOLATION MEDIUM W/CYCLOHEX
K834122 · KIT
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 76d
Cleared Feb 13, 1984
CHLAMYDIAL TRANSPORT MEDIUM
K834125 · JSM
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 76d
Cleared Feb 13, 1984
CARDIOVASCULAR SPRING GUIDE WIRE
K834223 · DQX
Mallinckrodt Critical Care
Cardiovascular · 69d
Cleared Feb 13, 1984
RAAF DUAL LUMEN CATH. REPAIR KIT 2.2
K834225 · LJS
Quinton, Inc.
General Hospital · 69d
Cleared Feb 13, 1984
HDL CHOLESTEROL PRETREATMENT
K834251 · LBR
American Monitor Corp.
Chemistry · 68d
Cleared Feb 13, 1984
REFLOCHECK & GLUCOSE TEST STRIP SYS
K834271 · CGA
Boehringer Mannheim Corp.
Chemistry · 67d
Cleared Feb 13, 1984
UNICONDYLAR FIBER METAL KNEE
K834298 · HRY
Zimmer, Inc.
Orthopedic · 67d
Cleared Feb 13, 1984
MEDAID DUAL CHANNEL TENS
K834334 · GZJ
Par Medex , Ltd.
Neurology · 63d
Cleared Feb 13, 1984
DESERET NEONATAL CATHETER SET
K834393 · FOZ
Parke-Davis Co.
General Hospital · 61d
Cleared Feb 13, 1984
MODEL 1888 ALPHA COS/RESPIRATION CAR
K834460 · LLK
Spacelabs, Inc.
General Hospital · 56d
Cleared Feb 13, 1984
ENTERNAL FEEDING TUBE
K834562 · KNT
Sheridan Catheter Corp.
Gastroenterology & Urology · 47d
Cleared Feb 13, 1984
DIFFERENTIATION DISKS HIPPURATE
K834581 · JTO
Difco Laboratories, Inc.
Microbiology · 46d
Cleared Feb 13, 1984
ARTERIAL CANNULA STRAIGHT BEVELED TIP
K840001 · DWF
Dlp, Inc.
Cardiovascular · 41d
Cleared Feb 13, 1984
ARTERIAL CANNULA CURVED BEVELED TIP
K840002 · DWF
Dlp, Inc.
Cardiovascular · 41d
Cleared Feb 13, 1984
NABI RF-Q.S. TEST
K840005 · DHR
Intl. Diagnostic, Inc.
Immunology · 40d
Cleared Feb 13, 1984
CARDIOPLEGIA HEAT EXCHANGER HE-100
K840045 · DTR
American Bentley
Cardiovascular · 38d
Cleared Feb 13, 1984
CHOCOLATE AGAR GC BASE PLATE
K840065 · JTY
Otisville Biotech, Inc.
Microbiology · 35d
Cleared Feb 13, 1984
CHOCOLATE AGAR MUELLERH-HINTON BASE
K840066 · JTZ
Otisville Biotech, Inc.
Microbiology · 35d