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
160585–160608 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 1982
BECKMAN URIC ACID REAGENT
K821812 · KNK
Beckman Instruments, Inc.
Chemistry · 14d
Cleared Jul 02, 1982
BECKMAN URIC ACID STANDARD
K821813 · JIS
Beckman Instruments, Inc.
Chemistry · 14d
Cleared Jul 02, 1982
MODEL 1020 NA/K ANALYZER
K821822 · CEM
Thermo Orion
Chemistry · 10d
Cleared Jul 02, 1982
MODEL 100 BICARBONATE CONDUCTIVITY
K821834 · FKQ
Western Laboratories Corp.
Gastroenterology & Urology · 10d
Cleared Jul 02, 1982
BARRIER BURN SHEET
K821835 · KME
Uhi Corp.
General Hospital · 10d
Cleared Jul 02, 1982
MEDIGAS SUCTION/DRAINAGE EQUIPMENT
K821841 · GCX
Linde Div. Union Carbide Corp.
General Hospital · 10d
Cleared Jul 02, 1982
DIAGNOSTICS HDL CHOLESTEROL PRECIPITANT
K821852
Boehringer Mannheim Corp.
Chemistry · 9d
Cleared Jul 02, 1982
VISCO HANDEX-VARIOUS MODELS
K821855 · ION
Fred Sammons, Inc.
Physical Medicine · 9d
Cleared Jul 02, 1982
BK-2082 FOLDING STOCKING AID
K821856 · ILD
Fred Sammons, Inc.
Physical Medicine · 9d
Cleared Jul 02, 1982
BK-5305 MULTIPLE HAND GRID
K821857 · ION
Fred Sammons, Inc.
Physical Medicine · 9d
Cleared Jul 02, 1982
NOTIE STRETCH-LACE-VARIOUS MODELS
K821858 · ILD
Fred Sammons, Inc.
Physical Medicine · 9d
Cleared Jul 02, 1982
ORTHOLACE 4,5.6 EYELET
K821859 · ILD
Fred Sammons, Inc.
Physical Medicine · 9d
Cleared Jul 02, 1982
BK-6477 THE DERBY RAISED TOILET SEAT
K821860 · ILS
Fred Sammons, Inc.
Physical Medicine · 9d
Cleared Jul 02, 1982
BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 2000 AND 2000A
K827375
Cranbury Medical Labs, Inc.
Radiology · 80d
Cleared Jul 02, 1982
BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 800
K827376
Cranbury Medical Labs, Inc.
Radiology · 80d
Cleared Jul 02, 1982
ULTRASONIC CLEANER
K827508
Keymed House
Radiology · 81d
Cleared Jul 02, 1982
ADAC MODEL DPS-3300 DIGITAL PROCESSING SYSTEM
K827580
Adac Laboratories
Radiology · 18d
Cleared Jul 02, 1982
ADAC MODEL DPS-2800 DIGITAL PROCESSING SYSTEM
K827581
Adac Laboratories
Radiology · 18d
Cleared Jul 01, 1982
BX-1000 ISOMATIC
K820080 · IPF
Bloomex International, Inc.
Physical Medicine · 170d
Cleared Jul 01, 1982
ELECTRONIC MUSCLE EXERCISER
K821110 · IPF
Bloomex International, Inc.
Physical Medicine · 72d
Cleared Jun 30, 1982
CARD U.V. GERMICIDAL CHAMBER II
K820546 · KDJ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 120d
Cleared Jun 29, 1982
LAURE WRIST IMPLANT
K803031 · KWM
Laure Prosthetics, Inc.
Orthopedic · 578d
Cleared Jun 29, 1982
ARTERIAL BLOOD FILTER, #AF-1025
K820044 · DTM
Bentley Laboratories, Inc.
Cardiovascular · 173d
Cleared Jun 29, 1982
ENGSTOM EDITH
K821365 · BYD
Lkb Instruments, Inc.
Anesthesiology · 53d