FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

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174,955 results
90841–90864 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 1997
LIGHTLINE-M
K974240 · IZX
Wuestec Medical, Inc.
Radiology · 40d
Cleared Dec 22, 1997
ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL
K974423 · EAM
Sterling Diagnostic Imaging, Inc.
Radiology · 28d
Cleared Dec 22, 1997
ENDOLAP RESECTOSCOPE ROLLER ELECTRODE
K974515 · FAS
Endolap, Inc.
Gastroenterology & Urology · 20d
Cleared Dec 22, 1997
ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE
K974516 · FAS
Endolap, Inc.
Gastroenterology & Urology · 20d
Cleared Dec 22, 1997
SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY
K974551 · CEC
Sealite Sciences, Inc.
Chemistry · 18d
Cleared Dec 19, 1997
KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES
K962985 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 505d
Cleared Dec 19, 1997
PREFERENCE 60 AND PREFERENCE 60 TORIC
K963013 · LPL
CooperVision, Inc.
Ophthalmic · 507d
Cleared Dec 19, 1997
IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID
K964271 · EIA
Airel-West
Dental · 420d
Cleared Dec 19, 1997
CLIRANS T-SERIES HOLLOW FIBER DIALYZERS
K970708 · FJI
Terumo Medical Corp.
Gastroenterology & Urology · 296d
Cleared Dec 19, 1997
RADIAL AND FEMORAL ARTERY CATHETER
K971086 · DQX
B.Braun Medical, Inc.
Cardiovascular · 269d
Cleared Dec 19, 1997
PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER...
K972314 · CCC
Diametrics Medical, Ltd.
Anesthesiology · 182d
Cleared Dec 19, 1997
AESOP 3000 SYSTEM AND ACCESSORIES
K972699 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 154d
Cleared Dec 19, 1997
ERBIUM 2000 LASER FAMILY
K972915 · GEX
Phantom Technologies, Inc.
General & Plastic Surgery · 134d
Cleared Dec 19, 1997
AURELUX 77
K972946 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 182d
Cleared Dec 19, 1997
DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES
K973291 · FJI
Dynamic Technology Corp.
Gastroenterology & Urology · 108d
Cleared Dec 19, 1997
VALLEY FORGE BIPOLAR BALL TIP ELECTRODE
K973554 · JOS
Valley Forge Scientific Corp.
General & Plastic Surgery · 91d
Cleared Dec 19, 1997
THE POSTERIOR STABILISED NUFFIELD TOTAL KNEE SYSTEM
K973595 · JWH
Corin USA
Orthopedic · 88d
Cleared Dec 19, 1997
SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 1064/532 LASER SYSTEM
K973603 · GEX
Schwartz Electro-Optics, Inc.
General & Plastic Surgery · 88d
Cleared Dec 19, 1997
SKYVAL
K973610 · FYD
Pyramid Air Systems
General Hospital · 88d
Cleared Dec 19, 1997
SOMNOPLASTY SYSTEM
K973618 · GEI
Somnus Medical Technologies, Inc.
General & Plastic Surgery · 87d
Cleared Dec 19, 1997
NATURAL-HIP POROUS STEM WITH OFFSET
K973675 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 84d
Cleared Dec 19, 1997
NATURAL-HIP COCR OFFSET STEM
K973681 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 84d
Cleared Dec 19, 1997
REVELATION POROUS HIP STEM
K973685 · LPH
Encore Orthopedics, Inc.
Orthopedic · 84d
Cleared Dec 19, 1997
TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL
K973708 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 81d