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
150793–150816 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 14, 1984
CONCEP-7-BHCG (EIA)
K844153 · JHI
Leeco Diagnostics, Inc.
Chemistry · 51d
Cleared Dec 14, 1984
API UNISCEPT MIC 100UL
K844159 · LTW
Analytical Products, Inc.
Microbiology · 51d
Cleared Dec 14, 1984
DIAGONAL PIN CUTTER
K844599
Med-Tool, Inc.
General & Plastic Surgery · 17d
Cleared Dec 14, 1984
SLIP JOINT PLIERS
K844600 · HTC
Med-Tool, Inc.
General & Plastic Surgery · 17d
Cleared Dec 14, 1984
V. MUELLER PHEUMO-INTESTINAL INSTRUMENT SET
K844628 · GAG
American V. Mueller
General & Plastic Surgery · 17d
Cleared Dec 13, 1984
LASERSPEC
K841430
Clement Clarke, Inc.
Ophthalmic · 251d
Cleared Dec 13, 1984
PHILIPS SDR 1200
K842900 · IYO
Philips Medical Systems, Inc.
Radiology · 143d
Cleared Dec 13, 1984
CIVCO-SUPER SCAN/BIOPSY GUIDE
K843573 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 93d
Cleared Dec 13, 1984
DRY TRAY
K843782 · EFQ
E.M. Adams
General & Plastic Surgery · 78d
Cleared Dec 13, 1984
ULTRA & ULTRA MINATURE
K843789 · ESD
Qualitone
Ear, Nose, Throat · 77d
Cleared Dec 13, 1984
STERILE PERCUTANEOUS TRANSHEPATIC CHOLAN
K843883
Applied Medical Devices, Inc.
General & Plastic Surgery · 72d
Cleared Dec 13, 1984
GENERAL UTILITY TRAY SYSTEM
K843884
Applied Medical Devices, Inc.
General & Plastic Surgery · 72d
Cleared Dec 13, 1984
PYRIDOXAL DISC
K844020 · JTO
Remel Co.
Microbiology · 59d
Cleared Dec 13, 1984
E-COLI-CHEK TUBE
K844276 · JTO
E-Y Laboratories, Inc.
Microbiology · 38d
Cleared Dec 13, 1984
INRA MENEZO B2 MEDIA
K844288 · KIT
Fcs Laboratories, Inc.
Hematology · 38d
Cleared Dec 13, 1984
MIST-EASE NEBULIZER
K844591 · CCQ
General Physiotherapy, Inc.
Anesthesiology · 17d
Cleared Dec 12, 1984
TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL
K842886 · GWN
Teca, Inc.
Neurology · 142d
Cleared Dec 12, 1984
MED. DYNAMICS SATICAN VIDEO CAMERA 5410
K843294 · KQM
Medline Industries, Inc.
General & Plastic Surgery · 113d
Cleared Dec 12, 1984
MED. DYNAMICS HIGH RESOLUTION SOLID ST
K843295 · KQM
Medline Industries, Inc.
General & Plastic Surgery · 113d
Cleared Dec 12, 1984
HEMOTEC ACT I SYSTEM
K843459 · JBP
Hemotec, Inc.
Hematology · 98d
Cleared Dec 12, 1984
TRI-COUNT LASER
K843485 · JPK
Hematology Marketing Assoc.
Hematology · 97d
Cleared Dec 12, 1984
UROPAPER EIKEN 8
K843532 · KHE
Syn-Kit, Inc.
Chemistry · 96d
Cleared Dec 12, 1984
ORTHO BRAIN THROMBOPLASTIN DILUENT
K843535 · GJS
Ortho Diagnostic Systems, Inc.
Hematology · 96d
Cleared Dec 12, 1984
AMS ANA CARD
K843686 · JSP
Vitek Systems, Inc.
Microbiology · 85d