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
137737–137760 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 1987
TRAUMA-TRODE, ECG ELECTRODE (597 ADHESIVE)
K874437 · DRX
Labeltape Meditect, Inc.
Cardiovascular · 63d
Cleared Dec 30, 1987
MULTI-ALLERGEN IGE FAST SCREEN (ENVIRONMENTAL)
K874446 · DHB
3M Company
Immunology · 63d
Cleared Dec 30, 1987
MC/CPAP MANIFOLD
K874479 · BYE
Minneapolis Children'S Services Corp.
Anesthesiology · 58d
Cleared Dec 30, 1987
MONAGHAN AEROCHAMBER WITH MASK
K874513 · CCQ
Monaghan Medical Corp.
Anesthesiology · 58d
Cleared Dec 30, 1987
STERILE SURGICAL SCRUB BRUSH
K874653 · GEC
Surgikos, Inc.
General & Plastic Surgery · 47d
Cleared Dec 30, 1987
COLLI-MATETM MODEL NO. B800
K874687 · IZX
Summit Industries, Inc.
Radiology · 47d
Cleared Dec 30, 1987
COLORED CASTING TAPE CARAGLAS(TM GREEN
K874880 · LGF
Synthetic Mfg., Inc.
Orthopedic · 29d
Cleared Dec 30, 1987
ISOLATION GOWN
K874888 · FYC
Sage Products, Inc.
General Hospital · 29d
Cleared Dec 30, 1987
U.V. SUNLAMP 95 UF-11
K874889 · FTC
Light Sources, Inc.
General & Plastic Surgery · 29d
Cleared Dec 30, 1987
WHOLEY (TM) BIOPSY DEVICE
K874928 · GDM
Medrad, Inc.
General & Plastic Surgery · 28d
Cleared Dec 30, 1987
MICROSURGICAL INSTRUMENTS
K874950 · HTD
Solway, Inc.
General & Plastic Surgery · 28d
Cleared Dec 30, 1987
MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES
K874952 · HBG
Solway, Inc.
Neurology · 28d
Cleared Dec 30, 1987
MANUAL RONGEUR
K874954 · HTX
Solway, Inc.
Orthopedic · 28d
Cleared Dec 30, 1987
VASCULAR CLAMP
K874959 · HXD
Solway, Inc.
General & Plastic Surgery · 28d
Cleared Dec 30, 1987
BONE CUTTING INSTRUMENTS & ACCESSORIES
K874961 · GDR
Solway, Inc.
General & Plastic Surgery · 28d
Cleared Dec 30, 1987
MANUAL SURGICAL INSTRUMENTS FOR GENERAL USE
K874965 · HTD
Solway, Inc.
General & Plastic Surgery · 28d
Cleared Dec 30, 1987
ACE AND ACE/FISCHER PRE-DRILL PIN SYSTEM
K875021 · JDW
Buckman Co., Inc.
Orthopedic · 26d
Cleared Dec 29, 1987
QUIK-PACE NONINVASIVE PACEMAKER
K871751 · DRO
Physio-Control Corp.
Cardiovascular · 235d
Cleared Dec 29, 1987
COMBINATION NITE DRAINAGE UNIT
K872294 · EXB
Arnold Technologies
Gastroenterology & Urology · 196d
Cleared Dec 29, 1987
OMNIFIT DISTAL STEM CEMENT SPACERS
K872528 · JDK
Osteonics Corp.
Orthopedic · 187d
Cleared Dec 29, 1987
DUOFLO DISPENSER
K872565 · FMF
Hemaedics, Inc.
General Hospital · 183d
Cleared Dec 29, 1987
FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER
K872767 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 168d
Cleared Dec 29, 1987
EASI LEAD SYSTEM CABLE ASSEMBLY
K872781 · DRW
Totemite Medical Electronics
Cardiovascular · 168d
Cleared Dec 29, 1987
INSURE PORCELAIN VENEER BONDING SYSTEM
K873356 · EMA
Cosmedent, Inc.
Dental · 131d