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
70369–70392 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 14, 2004
NASAL-AIR CRITICAL CARE
K031896 · MNS
Innomed Technologies
Anesthesiology · 209d
Cleared Jan 14, 2004
MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND...
K031908 · CAF
Med2000 S.R.L.
Anesthesiology · 208d
Cleared Jan 14, 2004
ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE...
K032245 · GAT
Arthrex, Inc.
General & Plastic Surgery · 176d
Cleared Jan 14, 2004
AEROCHAMBER MAX VALVED HOLDING CHAMBER
K032972 · CAF
Trudell Medical Intl.
Anesthesiology · 112d
Cleared Jan 14, 2004
ORACLE ORAL MASK, MODEL HC451A
K033087 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 107d
Cleared Jan 14, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN/CLAVULANATE-GRAM NEGATIVE
K033557 · LON
Becton, Dickinson & CO
Microbiology · 63d
Cleared Jan 14, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME 0.5-64...
K033560 · LON
Becton, Dickinson & CO
Microbiology · 63d
Cleared Jan 14, 2004
MODIFICATION TO V-CATH POLY PICC
K033853 · FOZ
Hdc Corp.
General Hospital · 34d
Cleared Jan 14, 2004
BARD ELIMINATOR PET BALLOON DILATORS
K033936 · KNQ
C.R. Bard, Inc.
Gastroenterology & Urology · 26d
Cleared Jan 13, 2004
SURGICAL MEDICAL DEVICE CAUTERY
K023506 · HQP
Modern Medical Equipment Mfg., Ltd.
Ophthalmic · 452d
Cleared Jan 13, 2004
IBL C3D-CIC EIA TEST
K032796 · CZW
Ibl GmbH
Immunology · 127d
Cleared Jan 13, 2004
THE ANSWER SCREW SUPPLEMENTATION SYSTEM
K032966 · HWC
Simplicity Orthopedic Solutions, LLC
Orthopedic · 112d
Cleared Jan 13, 2004
MODIFICATION TO JET-X HA COATED HALF PINS
K033289 · JDW
Smith & Nephew, Inc.
Orthopedic · 91d
Cleared Jan 13, 2004
MED-LOGICS, MODEL ML7090
K033293 · HNO
Med-Logics, Inc.
Ophthalmic · 91d
Cleared Jan 13, 2004
EBI TOP LOADING MAS SPINAL FIXATION SYSTEM
K033312 · NKB
Ebi, L.P.
Orthopedic · 91d
Cleared Jan 13, 2004
D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT...
K033323 · DTZ
Dideco S.P.A.
Cardiovascular · 90d
Cleared Jan 13, 2004
SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM
K033556 · KTT
Synthes (Usa)
Orthopedic · 62d
Cleared Jan 13, 2004
FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH
K033569 · KRA
Flowmedica, Inc.
Cardiovascular · 62d
Cleared Jan 13, 2004
MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT...
K033850 · JXG
Medtronic Neurosurgery
Neurology · 33d
Cleared Jan 12, 2004
OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR
K031147 · KNQ
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 277d
Cleared Jan 12, 2004
ROCHE ONLINE TDM QUINIDINE
K032332 · LBZ
Roche Diagnostics Corp.
Toxicology · 167d
Cleared Jan 12, 2004
ROCHE ONLINE TDM LIDOCAINE
K032334 · KLR
Roche Diagnostics Corp.
Chemistry · 167d
Cleared Jan 12, 2004
ENDOPURE ROOT CANAL CLEANSER
K032361 · KJJ
Dentsply Intl.
Dental · 165d
Cleared Jan 12, 2004
BIOCENTREX CARDIAC PANEL
K033155 · MYT
Biocentrex
Chemistry · 104d