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
37705–37728 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 2014
DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM
K140417 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 141d
Cleared Jul 09, 2014
MERIT SAFETY INTRODUCER NEEDLE
K140513 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 131d
Cleared Jul 09, 2014
BIOFOAM BONE WEDGE
K140531 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 127d
Cleared Jul 09, 2014
INTRODUCER, MODEL ADELANTE MAGNUM
K140917 · DYB
Oscor, Inc.
Cardiovascular · 90d
Cleared Jul 09, 2014
ETEX MIXING AND DELIVERY SYSTEM
K141245 · FMF
Etex Corporation
General Hospital · 56d
Cleared Jul 09, 2014
CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW
K141417 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 41d
Cleared Jul 09, 2014
IMMULITE 2000
K141444 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 37d
Cleared Jul 08, 2014
WIRELESS THERMOMETER
K132761 · FLL
Raiing Medical Company
General Hospital · 307d
Cleared Jul 08, 2014
RESTORIS POROUS PARTIAL KNEE SYSTEM
K133811 · NJD
Mako Surgical Corp.
Orthopedic · 204d
Cleared Jul 08, 2014
BENDA WEDGE
K140144 · EJB
Centrix, Inc.
Dental · 167d
Cleared Jul 08, 2014
GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY
K140643 · MAI
Depuy Mitek, A Johnson and Johnson...
Orthopedic · 118d
Cleared Jul 08, 2014
POWDER FREE NITRILE EXAMINATION GLOVE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS...
K140816 · LZA
Better Care Plastic Technology Co., Ltd.
General Hospital · 98d
Cleared Jul 08, 2014
HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
K141102 · FRN
Hospira, Inc.
General Hospital · 70d
Cleared Jul 08, 2014
EZ-IO INTRAOSSEOUS INFUSION SYSTEM
K141117 · FMI
Vidacare, LLC
General Hospital · 69d
Cleared Jul 08, 2014
CT MIDLINE
K141151 · LJS
Medcomp (Medical Components, Inc.)
General Hospital · 64d
Cleared Jul 08, 2014
AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW
K141228 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 57d
Cleared Jul 08, 2014
WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE
K141273 · MRZ
Welldoc, Inc.
General Hospital · 53d
Cleared Jul 08, 2014
ARTHREX FRACTURE PLATES AND SCREWS
K141478 · HRS
Arthrex, Inc.
Orthopedic · 34d
Cleared Jul 08, 2014
ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS
K141618 · OBJ
Arrow International, Inc (Subsidiary...
Cardiovascular · 21d
Cleared Jul 07, 2014
DELL U3014 WITH QUBYX PERFECTLUM BUNDLE
K131601 · PGY
Qubyx Limited
Radiology · 399d
Cleared Jul 07, 2014
ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE,...
K132214 · NHA
Hager& Meisinger GmbH
Dental · 356d
Cleared Jul 07, 2014
GRAB 'N GO PLUS, GRAB 'N GO DIGITAL
K132778 · ECX
Praxair Healthcare Services
Anesthesiology · 305d
Cleared Jul 07, 2014
ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY
K133299 · KDI
Fresenius Medical Care, North America...
Gastroenterology & Urology · 255d
Cleared Jul 07, 2014
SYNGO, CT DUAL ENERGY
K133648 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 222d