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.

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

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175,820 results
146401–146424 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 1985
TITANIUIM BONE SCREW
K853869 · HWC
George Tiemann & Co.
Orthopedic · 83d
Cleared Dec 09, 1985
REGULATOR-INHALATOR SYSTEM
K853971 · BTL
Stephenson Industries, Inc.
Anesthesiology · 74d
Cleared Dec 09, 1985
POLYFLEX 483-09 ENDOCARDIAL IMPLANTABLE PACINGLEAD
K854069 · DTB
Intermedics, Inc.
Cardiovascular · 66d
Cleared Dec 09, 1985
SUPPORT ARM
K854162
Healthmate, Inc.
General & Plastic Surgery · 55d
Cleared Dec 09, 1985
MURPHY ADJUSTABLE SPLINT
K854270 · KQZ
Comfortex, Inc.
Orthopedic · 47d
Cleared Dec 09, 1985
TRICON UNICOMPARTMENTAL KNEE SYSTEM
K854325 · HSX
Richards Medical Co., Inc.
Orthopedic · 42d
Cleared Dec 09, 1985
KIRSCHNER INTRAMEDULLARY NAIL SYSTEM
K854338 · HSB
Kirschner Medical Corp.
Orthopedic · 42d
Cleared Dec 09, 1985
PULMO-AIDE MODEL 5610D
K854520 · CCQ
The Devilbiss Co.
Anesthesiology · 27d
Cleared Dec 09, 1985
KIRSCHNER SPINAL PRODUCT SYSTEM
K854524 · KWP
Kirschner Medical Corp.
Orthopedic · 27d
Cleared Dec 09, 1985
DISPOSABLE SYRINGES & NEEDLES
K854563 · FMF
Medelec Intl. Corp.
General Hospital · 25d
Cleared Dec 06, 1985
AMIZYME-CMV KIT
K842529 · GQI
Amico Lab, Inc.
Immunology · 526d
Cleared Dec 06, 1985
AMIZYME-EBV TEST KIT
K842530 · GNP
Amico Lab, Inc.
Immunology · 526d
Cleared Dec 06, 1985
AMIZYME-HSV TYPES 1 & 2 TEST KITS
K842531 · GQO
Amico Lab, Inc.
Immunology · 526d
Cleared Dec 06, 1985
ANTI-CYTOMEGALOVIRUS KIT
K842661 · GQI
Amico Lab, Inc.
Immunology · 514d
Cleared Dec 06, 1985
ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2
K842663 · GQO
Amico Lab, Inc.
Immunology · 514d
Cleared Dec 06, 1985
ARTHOPOR-ACETABULAR COMPONENT
K844050 · JDI
Joint Medical Products Corp.
Orthopedic · 415d
Cleared Dec 06, 1985
CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE
K853419 · BTO
Hood Laboratories
Anesthesiology · 114d
Cleared Dec 06, 1985
ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST
K853738 · LJP
Ortho Diagnostic Systems, Inc.
Microbiology · 91d
Cleared Dec 06, 1985
DEDO SUCTION CANNULA
K854005 · GEA
Dedo Manufacturer, Inc.
General & Plastic Surgery · 67d
Cleared Dec 06, 1985
EMPI, NMS/SUE CUTANEOUS ELECTRODE
K854513 · GXY
Empi
Neurology · 24d
Cleared Dec 06, 1985
PENICILLIN/STREPTOMYCIN SOLUTION
K854567 · KIT
Mediatech, Inc.
Pathology · 22d
Cleared Dec 06, 1985
MINI MASH 2000
K854602 · LIB
Dynatech Corp.
Pathology · 18d
Cleared Dec 06, 1985
MULTI MASH 2000
K854603 · LIB
Dynatech Corp.
Pathology · 18d
Cleared Dec 06, 1985
AUTO MASH
K854604 · LIB
Dynatech Corp.
Microbiology · 18d