FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
113161–113184 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 1993
3M MODEL 200RT RATE TAPER INFUSION PUMP
K926059 · FRW
3M Health Care, Ltd.
General Hospital · 258d
Cleared Aug 16, 1993
ANGIOGRAPHIC CATHETER
K926243 · DQO
Target Therapeutics
Cardiovascular · 248d
Cleared Aug 16, 1993
ENDOSCOPIC ULTRASOUND SYSTEM TYPE 20
K926514 · ODG
Olympus Corp.
Radiology · 229d
Cleared Aug 16, 1993
IMMULITE TSH THIRD GENERATION CONTROL
K930007 · JJX
Diagnostic Products Corp.
Chemistry · 224d
Cleared Aug 16, 1993
BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS
K930238 · HFS
Prolac, Inc.
General Hospital · 209d
Cleared Aug 16, 1993
GRASPING FORCEPS FLEXIBLE STONE DISLODGER
K930499 · OCZ
Endomedix
Gastroenterology & Urology · 196d
Cleared Aug 16, 1993
POWDERED EXAMINATION GLOVES
K930995 · LYY
P.T. Healthcare Glovindo
General Hospital · 172d
Cleared Aug 16, 1993
REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)
K931503 · JBD
Helena Laboratories
Hematology · 144d
Cleared Aug 16, 1993
IMMULITE TOTAL IGE
K931703 · JHR
Diagnostic Products Corp.
Immunology · 132d
Cleared Aug 16, 1993
IMMULITE FREE T4
K931704 · CEC
Diagnostic Products Corp.
Chemistry · 132d
Cleared Aug 16, 1993
COTUBE ESTRADIOL RADIOIMMUNOASSAY
K931740 · CHP
Bio-Rad
Chemistry · 131d
Cleared Aug 16, 1993
HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)
K931773 · LBR
King Diagnostics, Inc.
Chemistry · 129d
Cleared Aug 16, 1993
APO A-1 CHEMILUMINESCENCE ASSAY
K931777 · MSJ
Nichols Institute
Immunology · 129d
Cleared Aug 16, 1993
TPK CUTANEOUS ELECTRODE
K931925 · GXY
Staodyne, Inc.
Neurology · 122d
Cleared Aug 16, 1993
3M RED DOT 2330 RESTING EKG ELECTRODE
K932454 · DRX
3M Health Care, Ltd.
Cardiovascular · 87d
Cleared Aug 16, 1993
IRRIGATING TAPERED PROBE
K932804 · GCJ
Mayaguez Medical Center
General & Plastic Surgery · 68d
Cleared Aug 16, 1993
10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT
K932805 · GCJ
Mayaguez Medical Center
General & Plastic Surgery · 68d
Cleared Aug 16, 1993
SICKLE CELL TEST KIT
K932872 · JBB
Histo-Med, Inc.
Hematology · 63d
Cleared Aug 16, 1993
SUPERSTAND 3000
K933253 · IYB
Wuestec Medical, Inc.
Radiology · 45d
Cleared Aug 16, 1993
VIDAS THEOPHYLLINE(THEO)
K933258 · KLS
Biomerieux Vitek, Inc.
Toxicology · 41d
Cleared Aug 16, 1993
FUJI DAYLIGHT CASSETTE MULTI-LOADER
K933408 · IXW
Fujifilm Medical System U.S.A., Inc.
Radiology · 35d
Cleared Aug 15, 1993
NEW HYDROPHILIC COATING FOR WIRE GUIDES
K924385 · DQX
Arrow Intl., Inc.
Cardiovascular · 356d
Cleared Aug 13, 1993
IL TEST FIBRINOGEN-C
K931721 · KQJ
Instrumentation Laboratory CO
Hematology · 128d
Cleared Aug 12, 1993
ESCORT SPIROMETER
K925085 · BZG
Vitalograph , Ltd.
Anesthesiology · 309d