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
32305–32328 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 15, 2016
ACCU NEWS Drug Screening Test Card/Urine Cup
K152590 · DKZ
Coretests, Inc.
Toxicology · 218d
Cleared Apr 15, 2016
Leva Spacer System
K153222 · MAX
Spine Wave, Inc.
Orthopedic · 161d
Cleared Apr 15, 2016
MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit
K153343 · LNH
Siemens Medi Cal Solutions, Inc.
Radiology · 148d
Cleared Apr 15, 2016
Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators
K153361 · MRG
Fujirebio Diagnostics,Inc.
Chemistry · 147d
Cleared Apr 15, 2016
Bullfrog Micro-Infusion Device
K153501 · KRA
Mercator Medsystems, Inc.
Cardiovascular · 130d
Cleared Apr 15, 2016
Neodent Implant System
K153624 · NHA
Jjgc Industria E Comercio DE...
Dental · 119d
Cleared Apr 15, 2016
Accuryn Monitoring System
K153655 · EZL
Potrero Medical, Inc.
Gastroenterology & Urology · 116d
Cleared Apr 15, 2016
Forma System, Forma Light System
K160195 · ONF
Formatk Systems , Ltd.
General & Plastic Surgery · 79d
Cleared Apr 15, 2016
CRIT-LINE III Blood Chamber II
K160749 · KOC
Fresenius Medical Care Renal...
Gastroenterology & Urology · 28d
Cleared Apr 15, 2016
RIOScan (RPS500)
K160788 · MUH
Ray Co., Ltd.
Radiology · 24d
Cleared Apr 15, 2016
Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder...
K160792 · IYO
The Prometheus Group
Radiology · 23d
Cleared Apr 14, 2016
Nitrile Patient Examination gloves, Powderfree, Blue color
K143477 · LZA
Primus Gloves Pvt Limited
General Hospital · 496d
Cleared Apr 14, 2016
Nutraseb Facial Cream
K143605 · FRO
Isdin Corp.
General & Plastic Surgery · 482d
Cleared Apr 14, 2016
Symmetry Surgical Quad-Lock Container System
K152111 · KCT
Symmetry Surgical, Inc.
General Hospital · 260d
Cleared Apr 14, 2016
uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS
K152364 · LEJ
Pc Marketing, Inc.
General & Plastic Surgery · 237d
Cleared Apr 14, 2016
Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes
K152959 · KIF
Sybron Dental Specialties
Dental · 190d
Cleared Apr 14, 2016
Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff
K153251 · DXQ
Ningbo Free Trade Zone Tenso Medical...
Cardiovascular · 156d
Cleared Apr 14, 2016
Chattanooga Revolution Wireless
K153696 · IPF
Djo, LLC
Physical Medicine · 113d
Cleared Apr 14, 2016
MX30N(MX30TQS)
K160346 · PGY
Wide Corporation
Radiology · 66d
Cleared Apr 14, 2016
CX30N (CX30PQX)
K160348 · PGY
Wide Corporation
Radiology · 66d
Cleared Apr 14, 2016
The Nanostim Introducer Kit
K160716 · DYB
St. Jude Medical, Inc.
Cardiovascular · 30d
Cleared Apr 14, 2016
iPulse SmoothSkin Gold Hair Removal Device
K160968 · OHT
Cyden Limited
General & Plastic Surgery · 8d
Cleared Apr 13, 2016
SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS...
K143578 · MAX
Globus Medical, Inc.
Orthopedic · 483d
Cleared Apr 13, 2016
4plus6Line Abutment System
K151608 · NHA
Ot Medical GmbH
Dental · 303d