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
169105–169128 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 1979
TECHNICON HDL CHOLESTEROL METHOD
K791990 · LBS
Technicon Instruments Corp.
Chemistry · 14d
Cleared Oct 17, 1979
CREATININE DIAG. REAGENT PICRIC ACID
K791994 · CGX
Connecticut Diagnostics, Ltd.
Chemistry · 14d
Cleared Oct 12, 1979
PULSE GENERATOR MODEL 637
K790792 · DXY
Elema-Schonander, Inc.
Cardiovascular · 171d
Cleared Oct 12, 1979
PORTABLE PULSE GALVANIC STIMULATOR
K791087 · IPF
Staodynamics, Inc.
Physical Medicine · 122d
Cleared Oct 12, 1979
FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY
K791547 · DJB
Bio-Rad
Toxicology · 63d
Cleared Oct 11, 1979
AUTOPAK 12 T3 RIA TEST DELIVERY SYSTEM
K791375 · CDP
Micromedic Systems
Chemistry · 79d
Cleared Oct 11, 1979
ACU-ALERT
K791399
Acumed Instruments Corp.
Cardiovascular · 87d
Cleared Oct 11, 1979
MODEL 80-1765 ELECTROSURGICAL UNIT
K791415 · GEI
Cameron-Miller, Inc.
General & Plastic Surgery · 72d
Cleared Oct 11, 1979
TECHNICON FAST-LC SYS. FOR THEOPHYLLINE
K791431 · DPA
Technicon Instruments Corp.
Toxicology · 77d
Cleared Oct 11, 1979
ADAMCO DUST COVER
K791513 · FRG
Chase Mfg. Co.
General Hospital · 76d
Cleared Oct 11, 1979
TETRAHYDROCANNALBINOL DIRECT BLOOD KIT
K791649 · LAT
Immunalysis Corporation
Toxicology · 48d
Cleared Oct 11, 1979
MEDITEC (RODENSTOCK) LASER PHOTOCOAGUL
K791659 · HQF
Coburn Optical Ind., Inc.
Radiology · 50d
Cleared Oct 11, 1979
CDC ANAEROBIC BLOOD AGAR PHENETHYLAL
K791697 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 44d
Cleared Oct 11, 1979
COUNTER-CHECK PLUS
K791750 · JPK
Diagnostic Technology, Inc.
Hematology · 36d
Cleared Oct 11, 1979
BOVIE CSV HAND CONTROL ADAPTER
K791767 · GEI
Sybron Corp.
General & Plastic Surgery · 36d
Cleared Oct 11, 1979
COUNTER-CHECK PLUS NORMAL, HIGH ABN.
K791772 · JPK
Diagnostic Technology, Inc.
Hematology · 34d
Cleared Oct 11, 1979
ORTHO ANTIBODY ENHANCEMENT SOLUTION
K791791 · KSG
Ortho Diagnostics, Inc.
Hematology · 30d
Cleared Oct 11, 1979
MTS CATHETER ADAPTER FOR GUIDANCE ENTRY
K791797 · DTL
Medical Testing System, Inc.
Cardiovascular · 27d
Cleared Oct 11, 1979
M015 OXYGEN & MA15 AIR
K791900 · CAX
Timeter Instrument Corp.
Anesthesiology · 16d
Cleared Oct 11, 1979
3-WAY STOPCOCK W/MALE LOCKING LUER ADA.
K791914 · DTL
Abbott Laboratories
Cardiovascular · 16d
Cleared Oct 11, 1979
WRIGHTS RAPID STAIN
K791929 · IAF
Mcb Manufacturing Chemists, Inc.
Hematology · 14d
Cleared Oct 11, 1979
SERACON CAL D025
K791956 · JIX
Bhp Diagnostix, Inc.
Chemistry · 10d
Cleared Oct 11, 1979
SERACON -LO DO26
K791957 · JJX
Bhp Diagnostix, Inc.
Chemistry · 10d
Cleared Oct 11, 1979
MODEL 15055A MAINFRAME
K791964 · DRR
Hewlett-Packard Co.
Cardiovascular · 10d