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
168241–168264 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 1980
STERILIZATION PROCESS/MATERNITY PAD
K792627 · HIL
Procter & Gamble Mfg. Co.
Obstetrics & Gynecology · 40d
Cleared Jan 28, 1980
STERILIZATION PROCESS/DBL. GRIP CORD CLP
K792631 · KNA
Procter & Gamble Mfg. Co.
Obstetrics & Gynecology · 40d
Cleared Jan 28, 1980
HIGH RESOLUTION IMAGING SYSTEM
K792638 · IYO
Unirad Corp.
Radiology · 39d
Cleared Jan 28, 1980
HYDRO PULSE MASSAGE
K792641 · ILJ
Hydro-Pulse Research, Inc.
Physical Medicine · 33d
Cleared Jan 28, 1980
THE VARIABLE LOAD KENETIC ENERGIZER
K792642 · ION
W.F. Pogue
Physical Medicine · 33d
Cleared Jan 28, 1980
TRIOSKOP
K792645 · IXR
Siemens Corp.
Radiology · 33d
Cleared Jan 28, 1980
HAMAS PRECENTERED TOTAL WRIST
K792650 · JWJ
Zimmer, Inc.
Orthopedic · 38d
Cleared Jan 28, 1980
CAMPY BLOOD AGAR
K792674 · JSJ
Regional Media Laboratories
Microbiology · 32d
Cleared Jan 28, 1980
PARA-PAK CLEAN VIAL
K792710 · FMH
Meridian Diagnostics, Inc.
General Hospital · 32d
Cleared Jan 28, 1980
HEXCEL FEMORAL COMPONENT HIP PROSTHESIS
K800051 · JDG
Hexcel Medical
Orthopedic · 19d
Cleared Jan 28, 1980
ANAGO ELECTRO SURGICAL TIP CLEANER
K800058 · GEC
Anago, Inc.
General & Plastic Surgery · 18d
Cleared Jan 28, 1980
DIGITAL ELECTRONIC EXERCISER/PULSE MTR.
K800072 · ISD
Sears, Roebuck & Co.
Physical Medicine · 14d
Cleared Jan 28, 1980
VESSEL OCCLUDER
K800074 · GDJ
Cordis Corp.
General & Plastic Surgery · 14d
Cleared Jan 28, 1980
CRUTCH TIPS, PADS & HAND GRIPS
K800076 · INP
New World Imports, Inc.
Physical Medicine · 14d
Cleared Jan 28, 1980
HEMOCLIP SURGICAL OCCLUDING CLIP
K800079 · FZP
Edward Weck, Inc.
General & Plastic Surgery · 14d
Cleared Jan 28, 1980
STERILIZING CASE CAT. NO. 65199
K800080 · FLE
Edward Weck, Inc.
General Hospital · 14d
Cleared Jan 28, 1980
DAVOL/ABAMSON SILICONE SUMP DRAIN
K800081 · GCY
Davol, Inc.
General & Plastic Surgery · 14d
Cleared Jan 28, 1980
STANFORD STERILE LAP SPONGES
K800102 · GDY
Lukens Corp.
General & Plastic Surgery · 12d
Cleared Jan 28, 1980
SURGICAL STITCH CUTTER
K800103 · FZT
Macon & Co., Inc.
General & Plastic Surgery · 12d
Cleared Jan 24, 1980
NIC-200 VENTRICULAR FUNCTION ANALYZER
K792466 · DQC
Nicolet Biomedical Instruments
Cardiovascular · 52d
Cleared Jan 24, 1980
NEONATAL HEATED HUMIDIFIER
K792620 · BTT
Modern Medical Systems Co.
Anesthesiology · 5d
Cleared Jan 24, 1980
CULTURETTE BRAND-PVA/FORMALIN KIT
K792654 · IFQ
Marion Laboratories, Inc.
Pathology · 29d
Cleared Jan 24, 1980
HELENA COLOSCREEN
K792655 · KHE
Helena Laboratories
Hematology · 29d
Cleared Jan 24, 1980
HELENA FACTOR XII DEFICIENT
K792656 · GGP
Helena Laboratories
Hematology · 29d