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
48841–48864 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 07, 2010
ARCOS INTERLOCKING DISTAL STEMS
K100469 · KWA
Biomet Manufacturing Corp
Orthopedic · 292d
Cleared Dec 07, 2010
EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M
K100709 · DXG
Edwards Lifesciences, LLC
Cardiovascular · 270d
Cleared Dec 07, 2010
VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5
K100739 · KRB
Edwards Lifesciences, LLC
Cardiovascular · 266d
Cleared Dec 07, 2010
NEUMOVENT GRAPHNET MODEL 3179L1V
K101401 · CBK
Tecme S.A.
Anesthesiology · 203d
Cleared Dec 07, 2010
S 100 PEDICLE SCREW SYSTEM
K101682 · MNI
Renovis Surgical Technologies, LLC
Orthopedic · 175d
Cleared Dec 07, 2010
AIDERA DIASEND SYSTEM
K101806 · MRZ
Aidera AB
General Hospital · 162d
Cleared Dec 07, 2010
VIPER SYSTEM, EXPEDIUM SYSTEM
K101993 · NKB
Depuy Spine, Inc.
Orthopedic · 145d
Cleared Dec 07, 2010
SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM
K102095 · HRS
Suspension Orthopaedic Solutions, LLC
Orthopedic · 134d
Cleared Dec 07, 2010
SKELETAL DYNAMICS STERILIZATION TRAYS
K102103 · KCT
Skeletal Dynamics, LLC
General Hospital · 133d
Cleared Dec 07, 2010
MEDICAL MAGNETIC TAPE RECORDER
K102111 · DSI
Wpr Medical AS
Cardiovascular · 132d
Cleared Dec 07, 2010
THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT...
K102282 · HRS
Howmedica Osteonics Corp., Dba...
Orthopedic · 117d
Cleared Dec 07, 2010
NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201
K102376 · MHX
Nihon Kohden Corp.
Cardiovascular · 109d
Cleared Dec 07, 2010
SPACELABS MEDICAL PATIENT MONITORS
K102422 · MHX
Spacelabs Medical, Inc.
Cardiovascular · 104d
Cleared Dec 07, 2010
ARMADA 14 PTA CATHETER
K102705 · LIT
Abbott Vascular, Inc.
Cardiovascular · 78d
Cleared Dec 07, 2010
PRONEX
K102765 · IYE
Direx Systems Corp.
Radiology · 74d
Cleared Dec 06, 2010
GC AADVA IMPLANT SYSTEM
K093749 · DZE
GC America, Inc.
Dental · 364d
Cleared Dec 06, 2010
CRYOPETTE
K100596 · MQK
Mid-Atlantic Diagnostics, Inc.
Obstetrics & Gynecology · 279d
Cleared Dec 06, 2010
MEDICON MOGEN CLAMP
K100916 · HFX
Medicon EG
Obstetrics & Gynecology · 248d
Cleared Dec 06, 2010
PRECICONTROL HBA1C NORM
K103099 · JJX
Roche Diagnostics
Chemistry · 47d
Cleared Dec 06, 2010
EVERCROSS 0.035 OTW PTA DILATION CATHETER
K103322 · LIT
Ev3, Inc.
Cardiovascular · 24d
Cleared Dec 06, 2010
SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM
K103340 · JQC
Harvest Technologies, Corp.
Hematology · 21d
Cleared Dec 03, 2010
BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE...
K092587 · LFX
Bio-Rad Laboratories
Microbiology · 466d
Cleared Dec 03, 2010
PLEURAFLOW CATHETER SYSTEM
K093565 · OTK
Clear Catheter Systems
General & Plastic Surgery · 380d
Cleared Dec 03, 2010
BIOHARNESS
K100040 · MHX
Zephyr Technology Corporation
Cardiovascular · 330d