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
159049–159072 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 1982
BE #16 - MANIFOLD
K823481 · BZO
Instrumentation Industries, Inc.
Anesthesiology · 29d
Cleared Dec 22, 1982
THERMAL DILUTION CATHETER
K823484 · DYG
Instrumentation Laboratory CO
Cardiovascular · 29d
Cleared Dec 22, 1982
GLISLENS
K823528 · HPX
Bio-Products, Inc.
Ophthalmic · 22d
Cleared Dec 22, 1982
H 12 07
K823589 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 16d
Cleared Dec 22, 1982
PLASTIC BUILT-UP HANDLE EATING UTENSILS
K823594 · ILC
Fred Sammons, Inc.
Physical Medicine · 16d
Cleared Dec 22, 1982
HEAD SUPPORT FOR WHEELCHAIR
K823595 · KNO
Fred Sammons, Inc.
Physical Medicine · 16d
Cleared Dec 22, 1982
CLAMP ON HOLDER FOR A GLASS OR CUP
K823596 · KNO
Fred Sammons, Inc.
Physical Medicine · 16d
Cleared Dec 22, 1982
SOLID WOOD CONE
K823600 · IOD
Fred Sammons, Inc.
Physical Medicine · 16d
Cleared Dec 22, 1982
WRIST SUPPORT
K823601 · ILH
Fred Sammons, Inc.
Physical Medicine · 16d
Cleared Dec 22, 1982
REGULAR SHOE HORN W/CYLINDRICAL HANDLE
K823602 · ILD
Fred Sammons, Inc.
Physical Medicine · 16d
Cleared Dec 22, 1982
KIT OF WORDS & LTRS TO RE-LEARN-BK4014
K823609 · ILP
Fred Sammons, Inc.
Physical Medicine · 16d
Cleared Dec 22, 1982
BK-4015 ECONOMY COMMUNICATION SHEET
K823610 · ILP
Fred Sammons, Inc.
Physical Medicine · 16d
Cleared Dec 22, 1982
PLASTIC STOP TO HOLD TELEPHONE BUTTON
K823613 · ILP
Fred Sammons, Inc.
Physical Medicine · 16d
Cleared Dec 22, 1982
FLEXIBLE HOLDER TO HOLD PHONE RECEIVER
K823614 · ILP
Fred Sammons, Inc.
Physical Medicine · 16d
Cleared Dec 22, 1982
TELEPHONE ADAPTOR-PERSONS CANT ANSWER
K823615 · ILP
Fred Sammons, Inc.
Physical Medicine · 16d
Cleared Dec 22, 1982
PLASTIC SLIP-ON PEN/PENCIL HOLDER
K823616 · ILP
Fred Sammons, Inc.
Physical Medicine · 16d
Cleared Dec 22, 1982
PLASTIC SLIP-ON POINTS W/RUBBER TIP FOR
K823617 · ILP
Fred Sammons, Inc.
Physical Medicine · 16d
Cleared Dec 22, 1982
PROGRESSIVE RESISTANCE EXERCISE CUFF
K823618 · ION
Fred Sammons, Inc.
Physical Medicine · 16d
Cleared Dec 22, 1982
PLASTIC ELASTOMER ENCASED IN TERRY CLOTH
K823619 · ION
Fred Sammons, Inc.
Physical Medicine · 16d
Cleared Dec 22, 1982
PLASTIC ELASTOMER IN CUBE FORM EXERCISE
K823620 · ION
Fred Sammons, Inc.
Physical Medicine · 16d
Cleared Dec 22, 1982
TELEMETRY DECODER #540-02
K823678 · DXY
Intermedics, Inc.
Cardiovascular · 16d
Cleared Dec 22, 1982
VOLUME VENTILATOR
K823858 · CBK
Puritan Bennett Corp.
Anesthesiology
Cleared Dec 21, 1982
DATASCOPE MODEL 83 IABP SYSTEM
K821951 · DSP
Datascope Corp.
Cardiovascular · 174d
Cleared Dec 20, 1982
URIC ACID REAGENT
K822913 · KNK
Ac Biochemical Laboratories, Inc.
Chemistry · 80d