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
143617–143640 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 29, 1986
MVP GENERATOR, CATALOG NO. H8018
K862682 · IZO
General Electric Co.
Radiology · 14d
Cleared Jul 29, 1986
KALLESTAD SSA/SSB ENA TEST REAGENTS
K862710 · LLL
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Jul 29, 1986
DANIEL ORTHO BED LIFT AC
K862738 · ILK
Radco
Physical Medicine · 8d
Cleared Jul 29, 1986
Q50 MEDICAL TREADMILL
K862741 · IOL
Quinton, Inc.
Physical Medicine · 8d
Cleared Jul 28, 1986
LIBAN INTUBATOR
K861026 · CCW
Life Support Devices Co.
Anesthesiology · 132d
Cleared Jul 28, 1986
INHALATOR MODELS 8100, 10100 AND 10200
K862194 · CAW
U.O. Equipment Co.
Anesthesiology · 49d
Cleared Jul 28, 1986
MATTRESS COVER
K862380 · EYQ
Intera Corp.
Gastroenterology & Urology · 34d
Cleared Jul 28, 1986
STOPCOCK
K862691 · FMG
Ram Development
General Hospital · 13d
Cleared Jul 25, 1986
BICONDYLAR TOE PROSTHESIS
K860163
Depuy, Inc.
Orthopedic · 189d
Cleared Jul 25, 1986
OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTRO
K861173 · LNK
Trimedyne, Inc.
Gastroenterology & Urology · 119d
Cleared Jul 25, 1986
DIGITRON 3V,3VA,3VAC,3 HIGH RESOLUTION UPGRADE
K861429 · LLZ
Siemens Gammasonics, Inc.
Radiology · 100d
Cleared Jul 25, 1986
SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR
K861456 · HMP
Pantheon Products, Inc.
General & Plastic Surgery · 98d
Cleared Jul 25, 1986
ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS
K861733 · JIL
Kyoto Diagnostics, Inc.
Chemistry · 80d
Cleared Jul 25, 1986
COLLIMATOR MODEL A280BLMD & MODEL A280BLMP
K861941 · IZX
D&R X-Ray Products, Inc.
Radiology · 66d
Cleared Jul 25, 1986
COLLIMATOR MODEL A280BLE & MODEL A280-BLM
K861942 · IZW
D&R X-Ray Products, Inc.
Radiology · 66d
Cleared Jul 25, 1986
EXPENDAGUIDE MULTIPLE HIP PINNING GUIDE SYSTEM
K862279 · KTW
Orthospec, Inc.
Orthopedic · 39d
Cleared Jul 25, 1986
SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PIN
K862311 · KTT
Warsaw Orthopedic, Inc.
Orthopedic · 38d
Cleared Jul 25, 1986
STEINHAUSER TITANIUM MINI BONE PLATES & SCREWS
K862482 · JEY
Walter Lorenz Surgical, Inc.
Dental · 25d
Cleared Jul 24, 1986
ULTRASOUND IMAGING SYSTEM MODEL 280 SL
K860697 · IYO
Johnson & Johnson Professionals, Inc.
Radiology · 149d
Cleared Jul 24, 1986
HOWMEDICA KINEMATIC PLUS KNEE SYSTEM
K861266 · JWH
Howmedica Corp.
Orthopedic · 111d
Cleared Jul 24, 1986
INTELLIGRAPH(TM) PROGRAMMER
K861598 · FRN
Intelligent Medicine, Inc.
General Hospital · 86d
Cleared Jul 24, 1986
MERIDIAN IMAGING SYSTEM
K861737 · JOP
Johnson & Johnson Professionals, Inc.
Cardiovascular · 79d
Cleared Jul 24, 1986
ACUSON S319 TRANSDUCER
K862159 · JOP
Acuson Computed Sonography
Cardiovascular · 48d
Cleared Jul 24, 1986
MODIFIED I.V. START, RE-START, PEDI AND GERI-KIT
K862335
U.S. Mfg. & Management, Inc.
General & Plastic Surgery · 35d