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
70777–70800 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 25, 2003
MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS
K033567 · MOS
Mri Devices Corp.
Radiology · 15d
Cleared Nov 25, 2003
ATR 5000, LC 5000, IMPLANT SYSTEM
K033597 · EKX
Advanced Technology Research (A.T.R.)...
Dental · 11d
Cleared Nov 24, 2003
IMMUNICON CELLTRACKS ANALYZER
K030263 · GKZ
Immunicon Corp.
Hematology · 301d
Cleared Nov 24, 2003
GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML
K031419 · KPE
Laboratorios Grifols, S.A.
General Hospital · 203d
Cleared Nov 24, 2003
SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
K032598 · MPA
Synergetics, Inc.
Ophthalmic · 91d
Cleared Nov 24, 2003
BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG
K032713 · LSR
Boston Biomedica, Inc.
Microbiology · 83d
Cleared Nov 24, 2003
CEDIA VANCOMYCIN ASSAY
K032811 · LEH
Microgenics Corp.
Toxicology · 76d
Cleared Nov 24, 2003
HBA SPERM-HYALURONAN BINDING ASSAY
K032874 · POV
Biocoat, Inc.
Hematology · 70d
Cleared Nov 24, 2003
MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
K033492 · MHX
Ge Medical Systems Information...
Cardiovascular · 20d
Cleared Nov 24, 2003
ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
K033548 · KHE
Roche Diagnostics Corp.
Chemistry · 12d
Cleared Nov 24, 2003
SMART OFFSET STAPES PISTON
K033554 · ETB
Gyrus Ent LLC
Ear, Nose, Throat · 12d
Cleared Nov 21, 2003
CONTEC DUO, CONTEC LC, CONTEC LCR
K030644 · DYH
Dentaurum
Dental · 266d
Cleared Nov 21, 2003
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K031842 · PDU
Intra Luminal Therapeutics, Inc.
Cardiovascular · 158d
Cleared Nov 21, 2003
ELECTRO FLO PERCUSSOR, MODEL 5000
K031876 · BYI
Med Systems
Anesthesiology · 157d
Cleared Nov 21, 2003
OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071
K032665 · JIX
Olympus America, Inc.
Chemistry · 85d
Cleared Nov 21, 2003
AERONEB GO NEBULIZER, MODEL AG-AG2000
K032849 · CAF
Aerogen, Inc.
Anesthesiology · 70d
Cleared Nov 21, 2003
UNIMARK HOME PREGNANCY TEST DEVICE
K032992 · LCX
Biotech Atlantic, Inc.
Chemistry · 57d
Cleared Nov 21, 2003
PROTEMP 3 GARANT
K033022 · EBG
3M Espe AG Dental Products
Dental · 57d
Cleared Nov 21, 2003
ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP
K033041 · LCX
ACON Laboratories, Inc.
Chemistry · 53d
Cleared Nov 21, 2003
PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
K033314 · FGE
Ev3, Inc.
Gastroenterology & Urology · 37d
Cleared Nov 21, 2003
BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER
K033441 · DQY
Boston Scientific Corp
Cardiovascular · 23d
Cleared Nov 21, 2003
PHILIPS MEDICAL SYSTEMS, M3012A- HEMODYNAMIC EXTENSION TO THE...
K033444 · MHX
Philips Medical Systems
Cardiovascular · 23d
Cleared Nov 21, 2003
LMT NOMAG IC 1,5
K033565 · FPL
Lmt Lammers Medical Technology GmbH
General Hospital · 9d
Cleared Nov 20, 2003
PLV CONTINUUM VENTILATOR, MODEL P1000
K022750 · NOU
Respironics California, Inc.
Anesthesiology · 458d