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
38185–38208 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 2014
APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE
K141041 · OTD
Aptus Endosystems
Cardiovascular · 23d
Cleared May 15, 2014
XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK
K130915 · JJE
Jas Diagnostics, Inc.
Chemistry · 408d
Cleared May 15, 2014
FETAL MONITORS
K131941 · HGM
Guangdong Biolight Meditech Co., Ltd.
Obstetrics & Gynecology · 322d
Cleared May 15, 2014
EXTRICARE
K132225 · OMP
Devon Medical, Inc.
General & Plastic Surgery · 302d
Cleared May 15, 2014
RXG DISTRACTION SYSTEM
K133304 · JEY
KLS-Martin L.P.
Dental · 199d
Cleared May 15, 2014
SMITH & NEPHEW CANNULATED CAPTURED SCREW
K133662 · HWC
Smith & Nephew, Inc.
Orthopedic · 167d
Cleared May 15, 2014
ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS
K133664 · KGI
Ge Medical Systems Ultrasound &...
Radiology · 167d
Cleared May 15, 2014
SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR...
K133752 · ELC
Sonendo, Inc.
Dental · 157d
Cleared May 15, 2014
SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM
K133763 · FCG
Medi-Globe Corporation
Gastroenterology & Urology · 155d
Cleared May 15, 2014
FIREFLY
K134001 · NGX
Firstkind Limited
Physical Medicine · 139d
Cleared May 15, 2014
INFUSET FLOW CONTROL EXTENSION SET
K140133 · FPA
Emed Technologies Corporation
General Hospital · 118d
Cleared May 15, 2014
RAY STATION
K140187 · MUJ
Raysearch Laboratories AB
Radiology · 111d
Cleared May 15, 2014
XGEO GR40CW
K140235 · MQB
Samsung Electronics Co., Ltd.
Radiology · 105d
Cleared May 15, 2014
RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT
K140329 · KRA
Boston Scientific
Cardiovascular · 94d
Cleared May 15, 2014
NXSTAGE PUREFLOW SL
K140571 · FKR
Nxstage Medical, Inc.
Gastroenterology & Urology · 70d
Cleared May 15, 2014
SALVATION BEAMS AND BOLTS SYSTEM
K140741 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 51d
Cleared May 15, 2014
CHARLOTTE CAROLINA JONES FRACTURE SYSTEM SCREW
K140952 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 31d
Cleared May 15, 2014
6VT-D ULTRASOUND TRANSDUCER
K141093 · ITX
Ge Vingmed Ultrasound AS
Radiology · 17d
Cleared May 14, 2014
QUICKSCREEN AMPHETINE 500 TEST
K131069 · DKZ
Phamatech, Inc.
Toxicology · 392d
Cleared May 14, 2014
NEOPLATE SPINE ANTERIOR FIXATION SYSTEM
K132653 · KWQ
Neoortho Productos Orthopedicos S/A
Orthopedic · 261d
Cleared May 14, 2014
OMNIPORE CUSTOMIZED SURGICAL IMPLANTS
K133046 · KKY
Matrix Surgical Holdings, LLC/Matrix...
General & Plastic Surgery · 229d
Cleared May 14, 2014
SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
K133153 · MNH
Spinefrontier, Inc.
Orthopedic · 209d
Cleared May 14, 2014
CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM
K133620 · OAS
Imaging Sciences International
Radiology · 170d
Cleared May 14, 2014
ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY...
K133700 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 162d