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

Filters: Cleared only ×
176,076 results
168193–168216 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 1980
IMMUNOGLOBULIN G REAGENT SYSTEM
K800119 · DEW
Calbiochem-Behring Corp.
Immunology · 18d
Cleared Feb 05, 1980
TECHNICON C/90 SYSTEM
K800121 · GKZ
Technicon Instruments Corp.
Hematology · 18d
Cleared Feb 05, 1980
ULTRASOFT GOWN
K800124 · FYA
Mars Mfg Co.
General Hospital · 18d
Cleared Feb 05, 1980
PLATELET AGGREGATION REAGENTS
K800146 · JOZ
Pacific Hemostasis
Hematology · 14d
Cleared Feb 05, 1980
EMIT TOBRAMYCIN ASSAY
K800150 · LCD
Syva Co.
Toxicology · 14d
Cleared Feb 05, 1980
EMIT TOBRAMYCIN CONTROL
K800151 · DPW
Syva Co.
Toxicology · 14d
Cleared Feb 05, 1980
TOTE-BRUSH
K800154 · EFW
Anja Marketing, Inc.
Dental · 13d
Cleared Feb 05, 1980
VIMEDIC SYSTEM TM
K800163 · EFA
Medical Systems Group of Viskay, Inc.
Dental · 11d
Cleared Feb 05, 1980
IMMUNOGLOBULIN M REAGENT SYSTEM
K800167 · DFT
Calbiochem-Behring Corp.
Immunology · 11d
Cleared Feb 05, 1980
SIROPORT
K800172 · KLC
Siemens Corp.
Dental · 11d
Cleared Feb 05, 1980
MEDTRONIC PISCES GENERATION II LEAD KIT
K800193 · GZB
Medtronic Vascular
Neurology · 7d
Cleared Feb 01, 1980
CONPHAR SURGICAL RAZORR
K791798 · LDQ
Conphar, Inc.
General & Plastic Surgery · 140d
Cleared Feb 01, 1980
MONOJECT PLASTIC DENTAL INJ. SYRINGE
K792541 · EJI
Sherwood Medical Co.
Dental · 53d
Cleared Feb 01, 1980
MICROPITETTE
K792696 · JRC
Meridian Diagnostics, Inc.
Chemistry · 36d
Cleared Feb 01, 1980
CORTEX DOUBLE HELIX SAMPLER
K800003 · GLE
Cortex Research Corp.
Hematology · 30d
Cleared Feb 01, 1980
DINAMAP RESEARCH MONITOR 1245
K800025 · DXN
Applied Medical Research
Cardiovascular · 25d
Cleared Feb 01, 1980
HANCOCK AORTIC PUNCH
K800122 · DWS
Hancock Laboratories, Inc.
Cardiovascular · 14d
Cleared Feb 01, 1980
CARDIOPLEGIA ADMINISTRATION SYSTEM CAS
K800135 · KRJ
Bentley Laboratories, Inc.
Cardiovascular · 11d
Cleared Feb 01, 1980
DIAGNOSTIC INTRAVASCULAR CATHETER
K800171 · DQO
Flomed, Inc.
Cardiovascular · 7d
Cleared Jan 31, 1980
PACING SYSTEM ANALYZER PSA SCE-22
K791975 · DTC
Ela Medical, Inc.
Cardiovascular · 121d
Cleared Jan 31, 1980
TELEMETRY SYSTEM XMT-1 & REC-1
K792371 · GYE
Burdick Corp.
Neurology · 66d
Cleared Jan 31, 1980
CYNERGY MODEL 182
K792536 · DTE
Cynergy
Cardiovascular · 55d
Cleared Jan 31, 1980
MINI-CEARS COMPUTER (MODEL 1)
K800001 · GWS
Bik Foundation, Inc.
Neurology · 29d
Cleared Jan 31, 1980
MICROTHIN-DI
K800026 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 24d