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
170113–170136 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 1979
NEONATAL TY AUTOPAK TEST DELIVERY SYSTEM
K790665 · CDX
Micromedic Systems
Chemistry · 39d
Cleared May 15, 1979
LD-P REAGENT (LDH P-L REAGENT)
K790771 · CFJ
Gilford Diagnostics
Chemistry · 25d
Cleared May 15, 1979
CULTURETTE BRAND PVA
K790815 · IGM
Marion Laboratories, Inc.
Pathology · 18d
Cleared May 15, 1979
EMIT GENTAMICIN ASSAY
K790829 · DJB
Syva Co.
Toxicology · 15d
Cleared May 15, 1979
EMIT GENTAMICIN CONTROL
K790830 · LAS
Syva Co.
Toxicology · 15d
Cleared May 15, 1979
PERMOBIL EXTERIOR
K790858 · ITI
Saab-Scania of America, Inc.
Physical Medicine · 12d
Cleared May 15, 1979
PERMOBIL SUPERIOR
K790859 · ITI
Saab-Scania of America, Inc.
Physical Medicine · 12d
Cleared May 14, 1979
DRESSING, ENVIRON WOUND
K782008 · KMF
Abbott Laboratories
General & Plastic Surgery · 164d
Cleared May 14, 1979
PISTORMATIC
K790104 · KZH
Zelby, Burstein, Hartman & Burstein
General Hospital · 118d
Cleared May 14, 1979
OPTIONAL ACCESSORY FOOT SWITCH MODEL 100
K790322 · EBW
Applied Medical Research
Dental · 88d
Cleared May 14, 1979
IMPLANTABLE HEART LEAD TERMINAL ADAPTER
K790436 · DTD
Arco Medical Products Co.
Cardiovascular · 68d
Cleared May 14, 1979
ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2
K790519 · FAP
American Medical Systems, Inc.
Gastroenterology & Urology · 59d
Cleared May 14, 1979
DROP CONTROLLER
K790669 · FLN
Imed Corp.
General Hospital · 38d
Cleared May 14, 1979
THE SURGICAL ASSISTANT
K790674 · FWZ
Instrument Makar, Inc.
General & Plastic Surgery · 35d
Cleared May 14, 1979
THE BIONIC EXERCISER
K790746 · HCC
Scudder Molner Instruments
Neurology · 28d
Cleared May 14, 1979
COLOSTOMY DEVICE W/ PRESSURE LID
K790750 · EXD
Vabar Corp.
Gastroenterology & Urology · 27d
Cleared May 14, 1979
PLATFORM TCCK TOTAL KNEE
K790762 · HRY
Biomet, Inc.
Orthopedic · 27d
Cleared May 14, 1979
ENCLOSED CASE CART
K790871
Hamilton Industries, Inc.
General & Plastic Surgery · 7d
Cleared May 11, 1979
FLUID MEASUREMENT STAND
K790365 · FFG
Hewlett-Packard Co.
Gastroenterology & Urology · 78d
Cleared May 11, 1979
FLOWMETER, OPTIFLO GAS
K790546 · DTX
Cobe Laboratories, Inc.
Cardiovascular · 52d
Cleared May 11, 1979
GREENLINE IRRIGATION TRAYS
K790607 · EYN
Snyder Laboratories, Inc.
General & Plastic Surgery · 43d
Cleared May 11, 1979
NUTRIFLOW NASOGASTRIC FEEDING TUBE
K790612 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 43d
Cleared May 11, 1979
INTRAUTERINE CATHETER TIP
K790678 · KXO
Sonicaid, Inc.
Radiology · 32d
Cleared May 11, 1979
BARRIER SURGICAL DRAPES W/ DRISITE* W/MICROCIDE*
K790725 · KKX
Surgikos, Inc.
General Hospital · 28d