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
165865–165888 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 1980
ARGYLE CONNECT TUBE-CON & NON
K802777 · GAZ
Sherwood Medical Co.
General Hospital · 36d
Cleared Dec 11, 1980
ELASTIC BANDAGE
K802785 · FQM
Secol Co.
General Hospital · 37d
Cleared Dec 11, 1980
OPRATEX ABDOMINAL PAD
K802798 · GDY
Secol Co.
General & Plastic Surgery · 37d
Cleared Dec 11, 1980
PARAGON HEMOGLOBIN ELECTRO. REAG. KIT
K802821 · JBD
Beckman Instruments, Inc.
Hematology · 31d
Cleared Dec 11, 1980
PARAGON LIPOPROTEIN ELECTRO. REAG. KIT
K802822 · JHO
Beckman Instruments, Inc.
Immunology · 31d
Cleared Dec 11, 1980
CHOLESTEROL STANDARDS
K802823 · JIT
Mallinckrodt Critical Care
Chemistry · 31d
Cleared Dec 11, 1980
COMBUNED CALCIUM AND PHOSPHORUS STD.
K802824 · JIX
Mallinckrodt Critical Care
Chemistry · 31d
Cleared Dec 11, 1980
COMBINED GLUCOSE AND BUN STANDARDS
K802825 · JIX
Mallinckrodt Critical Care
Chemistry · 31d
Cleared Dec 11, 1980
BOUIE ELECTROSURGICAL TIP CLEANER
K802827 · GEI
Sybron Corp.
General & Plastic Surgery · 31d
Cleared Dec 11, 1980
COMPU-CHEM II CHEMISTRY ANALYZER
K802835 · JJE
Diagnostic Aids, Inc.
Chemistry · 29d
Cleared Dec 11, 1980
SERIES 1800 EXERCISE TREADMILL
K802836 · IOL
Marquette Electronics, Inc.
Physical Medicine · 29d
Cleared Dec 11, 1980
STERNUM SAW BLADE
K802838 · GFA
Amsco Co.
General & Plastic Surgery · 29d
Cleared Dec 11, 1980
CARDIOPLEGIA COOLING SYST. CCAS-2
K802848 · DTR
Bentley Laboratories, Inc.
Cardiovascular · 29d
Cleared Dec 11, 1980
BECKMAN ICS DRUG CONTROL SERA
K802854 · DIF
Beckman Instruments, Inc.
Chemistry · 28d
Cleared Dec 11, 1980
IMMULON REMOVAWELL STRIPS #011-010-6301
K802857 · JTC
Dynatech Corp.
Microbiology · 29d
Cleared Dec 11, 1980
POST OP. SPONGES STERILE
K802860 · EFQ
Abco Dealers, Inc.
General & Plastic Surgery · 29d
Cleared Dec 11, 1980
COMBINATION PADS STERILE SINGLES
K802861 · EFQ
Abco Dealers, Inc.
General & Plastic Surgery · 29d
Cleared Dec 11, 1980
GAUZE PADS STERILE SINGLES
K802862 · EFQ
Abco Dealers, Inc.
General & Plastic Surgery · 29d
Cleared Dec 11, 1980
GAUZE SPONGES
K802863 · EFQ
Abco Dealers, Inc.
General & Plastic Surgery · 29d
Cleared Dec 11, 1980
BACKTRAC 90-90 TRACTION
K802869 · KQZ
Backtrac
Orthopedic · 27d
Cleared Dec 11, 1980
TIBIAL FRACTURE BRACE
K802871 · IQI
Orthomedics
Physical Medicine · 27d
Cleared Dec 11, 1980
AUFRANC-TURNER ATS TOTAL HIP SYSTEM
K802872 · JDI
Howmedica Corp.
Orthopedic · 27d
Cleared Dec 11, 1980
CULTURE MEDIA FOR IN VITRO DIAG. USE
K802892 · JSG
Radiation Technology, Inc.
Microbiology · 24d
Cleared Dec 10, 1980
DIALYSIS CONTROL UNIT-CENTRY 2000
K802250 · FKP
Cobe Laboratories, Inc.
Gastroenterology & Urology · 85d