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
74641–74664 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 2002
PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+1
K021690 · CBF
Pan-America Hyperbarics, Inc.
Anesthesiology · 155d
Cleared Oct 24, 2002
PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-S1
K021693 · CBF
Pan-America Hyperbarics, Inc.
Anesthesiology · 155d
Cleared Oct 24, 2002
INRATIO SELF-TEST
K021923 · GJS
Hemosense, Inc.
Hematology · 135d
Cleared Oct 24, 2002
AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM
K022217 · EIA
Aseptico, Inc.
Dental · 108d
Cleared Oct 24, 2002
CARDIO ID+(RZ153+)
K022540 · DSH
Rozinn Electronics, Inc.
Cardiovascular · 84d
Cleared Oct 24, 2002
SPOT PRO (220V), MODEL 131.099
K022741 · MUJ
Nucletron Corporation
Radiology · 66d
Cleared Oct 24, 2002
CLEARFIL AP-X PLT INTRO KIT
K022999 · EBF
Kuraray Medical, Inc.
Dental · 45d
Cleared Oct 24, 2002
QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM
K023058 · KXT
Seradyn
Toxicology · 41d
Cleared Oct 24, 2002
RANDOX APOLIPOPROTEIN CALIBRATOR
K023158 · JIX
Randox Laboratories, Ltd.
Chemistry · 31d
Cleared Oct 24, 2002
INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA...
K023182 · GEX
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 30d
Cleared Oct 24, 2002
E.CAM COMPUTER / E.SOFT WORKSTATION
K023190 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Oct 24, 2002
SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM
K023194 · CGA
Lifescan, Inc.
Chemistry · 29d
Cleared Oct 24, 2002
CEDIA CYCLOSPORINE PLUS ASSAY
K023208 · MKW
Microgenics Corp.
Chemistry · 29d
Cleared Oct 24, 2002
MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER
K023223 · DQY
Lumend, Inc.
Cardiovascular · 27d
Cleared Oct 24, 2002
CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES
K023475 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 8d
Cleared Oct 23, 2002
CMA CEREBRAL TISSUE MONITORING SYSTEM
K020285 · GWM
Cma Microdialysis AB
Neurology · 268d
Cleared Oct 23, 2002
MICROSCAN SYNERGIES PLUS
K023202 · JWY
Dade Microscan, Inc.
Microbiology · 28d
Cleared Oct 23, 2002
LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW
K023332 · JAK
GE Medical Systems
Radiology · 16d
Cleared Oct 22, 2002
SMITHWICK CAROTID SHUNT
K021608 · DXC
Implantable Devices
Cardiovascular · 159d
Cleared Oct 22, 2002
MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01
K022420 · HCG
Micrus Corp.
Neurology · 90d
Cleared Oct 22, 2002
INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED...
K022450 · DTZ
Dideco S.P.A.
Cardiovascular · 88d
Cleared Oct 22, 2002
MICROTECH PUSH BUTTON HANDPIECE, MODEL MHS-A100
K022535 · EFB
Microtech
Dental · 83d
Cleared Oct 22, 2002
EXCALIBUR 9000 TOTALSENSE QUAD HEAD ARRAY COIL
K022582 · MOS
Usa Instruments, Inc.
Radiology · 78d
Cleared Oct 22, 2002
HCMI X-RAY
K022667 · KPR
Health Care Mfg., Inc.
Radiology · 71d