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
168097–168120 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 1980
IPCO M-101 ECHOCARDIOGRAPH (IPCO ULTRA-
K792373 · DXK
Ipco Corp.
Cardiovascular · 79d
Cleared Feb 13, 1980
CALBIOCHEM-BEHRING RIA-COUNT
K792460 · CDD
Calbiochem-Behring Corp.
Chemistry · 72d
Cleared Feb 13, 1980
WHOLE BLOOD PLATELET CONTROL NORMAL,
K792606 · JPK
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 57d
Cleared Feb 13, 1980
MICROMEDIC PUNCH & ELUTER
K800075 · JQW
Micromedic Systems
Chemistry · 30d
Cleared Feb 13, 1980
SYSTEM 203 CHEMISTRY ANALYZER
K800085 · JJE
Gilford Instrument Laboratories, Inc.
Chemistry · 30d
Cleared Feb 13, 1980
LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS
K800106 · CEP
Radioimmunoassay, Inc.
Chemistry · 28d
Cleared Feb 13, 1980
FOLLICLE STIMULATING HORMONE
K800107 · CGJ
Radioimmunoassay, Inc.
Chemistry · 28d
Cleared Feb 13, 1980
CO2 CONTENT
K800111 · CIL
American Monitor Corp.
Chemistry · 28d
Cleared Feb 13, 1980
DURAZYME GPT/ALT
K800115 · CKA
American Monitor Corp.
Chemistry · 26d
Cleared Feb 13, 1980
DURAZYME GOT/AST
K800116 · CIT
American Monitor Corp.
Chemistry · 26d
Cleared Feb 13, 1980
LDH (L-P) REAGENT
K800120 · CFJ
Gilford Diagnostics
Chemistry · 26d
Cleared Feb 13, 1980
DEXTEX II STERILIZATION WRAP
K800123 · FRG
Ahlstrom Dexter
General Hospital · 26d
Cleared Feb 13, 1980
RSL (125 L) PROGESTERONE KIT
K800126 · JLS
Radioassay Systems Laboratories, Inc.
Chemistry · 26d
Cleared Feb 13, 1980
CENTRIFICHEM CK
K800127 · CGS
Union Carbide Corp.
Chemistry · 26d
Cleared Feb 13, 1980
CENTRIFICHEM BUN
K800128 · CDQ
Union Carbide Corp.
Chemistry · 26d
Cleared Feb 13, 1980
CENTRIFICHEM CREATININE
K800129 · CEX
Union Carbide Corp.
Chemistry · 26d
Cleared Feb 13, 1980
CENTRIFICHEM URIC ACID
K800130 · CDO
Union Carbide Corp.
Chemistry · 26d
Cleared Feb 13, 1980
TS-301 THREE-WAY PULP TESTER
K800138 · EAT
Tamler-Stoneham Instruments
Dental · 23d
Cleared Feb 13, 1980
ACCUSTROKE PIPET
K800141 · JQW
Beckman Instruments, Inc.
Chemistry · 23d
Cleared Feb 13, 1980
STAPHYLOCOCCUS MED. 110
K800156 · JSJ
Isle Media and Sterile Products, Inc.
Microbiology · 20d
Cleared Feb 13, 1980
BISMUTH SULFITE AGAR
K800157 · JSI
Isle Media and Sterile Products, Inc.
Microbiology · 20d
Cleared Feb 13, 1980
AZIDE BLOOD AGAR BASE W/&WTHOT SHP. BLD
K800158 · JSJ
Isle Media and Sterile Products, Inc.
Microbiology · 20d
Cleared Feb 13, 1980
VENTRE/SEP T3 UPTAKE RADIOASSAY
K800165 · KHQ
Ventrex Laboratories, Inc.
Chemistry · 19d
Cleared Feb 13, 1980
AMES RIALYZE - CHROMATOGRAPHY TUBES
K800169 · CDX
Miles Laboratories, Inc.
Chemistry · 19d