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

Filters: Cleared only ×
175,820 results
43273–43296 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 2012
ORIGINS LIPOHARVESTING SYSTEM
K120328 · MUU
Sound Surgical Technologies, LLC
General & Plastic Surgery · 228d
Cleared Sep 17, 2012
AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH...
K121022 · FIP
Ameriwater
Gastroenterology & Urology · 166d
Cleared Sep 17, 2012
TIGRAN PERIBRUSH
K121114 · ELB
Tigran Technologies AB
Dental · 158d
Cleared Sep 17, 2012
KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES
K121187 · HQF
Katalyst Surgical, LLC
Ophthalmic · 151d
Cleared Sep 17, 2012
BIOFIBER SYTURE
K122487 · NWJ
Tornier, Inc.
General & Plastic Surgery · 33d
Cleared Sep 17, 2012
SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS
K122506 · DQX
Surefire Medical, Inc.
Cardiovascular · 31d
Cleared Sep 14, 2012
AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE...
K100645 · DTZ
Medtronic, Inc.
Cardiovascular · 924d
Cleared Sep 14, 2012
CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR,...
K110053 · CAZ
Smiths Medical Asd, Inc.
Anesthesiology · 616d
Cleared Sep 14, 2012
STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR
K111375 · FRC
Advanced Sterilization Products
General Hospital · 487d
Cleared Sep 14, 2012
ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED,...
K113296 · LPH
Zimmer, Inc.
Orthopedic · 311d
Cleared Sep 14, 2012
SUPRA SCAN DELIVERY SYSTEM
K120825 · HQF
Quantel Medical
Ophthalmic · 179d
Cleared Sep 14, 2012
PEEK CUSTOMIZED CRAIAL IMPLANT KIT
K121153 · GWO
Stryker
Neurology · 151d
Cleared Sep 14, 2012
METAFIX FEMORAL HIP STEM SIZE 1
K121439 · LZO
Corin USA
Orthopedic · 122d
Cleared Sep 14, 2012
OXFORD ANKLE FUSION NAIL(AFN) SYSTEM
K121575 · HSB
Ortho Solutions Limited
Orthopedic · 107d
Cleared Sep 14, 2012
LULLABY TM WARMER
K121625 · FMT
Wipro GE Healthcare Private, Ltd.
General Hospital · 105d
Cleared Sep 14, 2012
IMAGER II ANGIOGRAPHIC CATHETER
K121694 · DQO
Boston Scientific Corp
Cardiovascular · 99d
Cleared Sep 13, 2012
LABONACHECK A1C
K111128 · LCP
Ceragem International, Inc.
Chemistry · 511d
Cleared Sep 13, 2012
STERRAD(R) 100NX STERILIZER DUO CYCLE
K111377 · MLR
Advanced Sterilization Products
General Hospital · 486d
Cleared Sep 13, 2012
POWDER FREE VINYL PATIENT EXAMINATION GLOVE
K112741 · LYZ
Lifestyle Safty Products (Hui Zhou)...
General Hospital · 358d
Cleared Sep 13, 2012
VIRTUOST
K113725 · KGI
O.N. Diagnostics
Radiology · 269d
Cleared Sep 13, 2012
IMMUNOCAP ALLERGEN COMPONENTS BUNDLE
K113841 · DHB
Phadia US, Inc.
Immunology · 260d
Cleared Sep 13, 2012
TRIA LASER HAIR REMOVAL SYSTEM
K120737 · GEX
Tria Beauty, Inc.
General & Plastic Surgery · 188d
Cleared Sep 13, 2012
VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM
K121078 · KWQ
Accel Spine
Orthopedic · 157d
Cleared Sep 13, 2012
G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE
K121335 · KGO
Hutchinson Sante S.N.C.
General Hospital · 133d