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
155281–155304 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 09, 1984
PREGNASTICK URINE HCG KIT
K833504 · JHJ
Monoclonal Antibodies, Inc.
Chemistry · 96d
Cleared Jan 09, 1984
MARZ-175 ARTERIAL BLOOD GAS SYRINGE
K833923 · CBT
Chesebrough-Pond'S U.S.A. Co.
Anesthesiology · 56d
Cleared Jan 09, 1984
NYLON COMPRESSION STUMP SHEATH
K834143
Ipos Luneburg
Physical Medicine · 39d
Cleared Jan 06, 1984
GORE-TEX SURGICAL MEMBRANE
K831516 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 302d
Cleared Jan 06, 1984
IRRIGATION ASPIRATION KIT
K833405 · HQC
American Medical Optics
Ophthalmic · 98d
Cleared Jan 04, 1984
M.S.D. ASPIRATOR
K832529 · HQC
Medical Surgical Designs
Ophthalmic · 159d
Cleared Jan 04, 1984
ASPIRATING HANDLE W/BACKFLUSHING CAPAB
K832560
Precision Medical Instruments, Inc.
Gastroenterology & Urology · 156d
Cleared Jan 04, 1984
OSCAR COLOUR VISION TESTER
K832843 · HIT
Keeler Instruments, Inc.
Ophthalmic · 135d
Cleared Jan 04, 1984
STORZ EXTRA
K833064 · HQC
Storz Instrument Co.
Ophthalmic · 118d
Cleared Jan 04, 1984
DISPOSABLE OCUTOME PROBE
K833371 · HQE
CooperVision, Inc.
Ophthalmic · 99d
Cleared Jan 04, 1984
CLERZ LUBRICATING/REWETTING SOLUTION
K833494 · HKX
CooperVision, Inc.
Ophthalmic · 89d
Cleared Jan 04, 1984
TITANGEL HIGH RESOLUTION CONTROL
K833639 · JJY
Helena Laboratories
Chemistry · 79d
Cleared Jan 04, 1984
ACA THYROXINE UPTAKE CALIBRATOR
K833702 · JIT
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 78d
Cleared Jan 04, 1984
COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE
K833708 · LKZ
Worthington Diagnostic Systems
Hematology · 76d
Cleared Jan 04, 1984
RIACOAT T-4
K833745 · CDX
Immuno Assay Corp.
Chemistry · 70d
Cleared Jan 04, 1984
TESTING VISUAL ACUITY
K833778 · HOX
Technical Enginuities Co.
Ophthalmic · 69d
Cleared Jan 04, 1984
BEECHER 20 GA. PROBE
K833800 · HQC
Beecher Medical Diagnostic...
Ophthalmic · 65d
Cleared Jan 04, 1984
MACHEMER/TANO ROTATING
K833820 · HRJ
Optical Micro Systems, Inc.
Ophthalmic · 63d
Cleared Jan 04, 1984
IL TEST IGG IGA & IGM KITS
K833841 · CZK
Instrumentation Laboratory CO
Chemistry · 58d
Cleared Jan 04, 1984
MAST INHALANT PROFILE
K833885 · DHB
Mast Immunosystems
Immunology · 56d
Cleared Jan 04, 1984
DOT VISUAL ACVITY TEST 2000
K833956 · HOX
Good-Lite Co.
Ophthalmic · 49d
Cleared Jan 04, 1984
MAST TOTAL IGE
K833969 · DGC
Mast Immunosystems
Immunology · 49d
Cleared Jan 04, 1984
ANTINUCLEAR ANTIBODY IMMUNOLOGICAL
K833984 · KTL
Intl. Diagnostic Technology
Immunology · 48d
Cleared Jan 04, 1984
TINSDALE ENRICHMENT
K834066 · JSK
Remel Co.
Microbiology · 40d