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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
68041–68064 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 2004
BD FACSCANTO WITH BD FACSANTO SOFTWARE
K041074 · GKZ
Bd Biosciences
Hematology · 144d
Cleared Sep 17, 2004
ORTHOFIBER
K041894 · GAT
Cp Medical
General & Plastic Surgery · 66d
Cleared Sep 17, 2004
XPLORER 1600
K042041 · MQB
Imaging Dynamics Company Limited
Radiology · 50d
Cleared Sep 17, 2004
CRONO F
K042085 · FRN
Cane S.R.L.
General Hospital · 45d
Cleared Sep 17, 2004
READY-HEAT BLANKET
K042145 · KME
Techtrade, LLC
General Hospital · 39d
Cleared Sep 17, 2004
ROBOCOUCH PATIENT SUPPORT SYSTEM
K042146 · JAI
Accuray Incorporated
Radiology · 39d
Cleared Sep 17, 2004
ORION ANTERIOR CERVICAL PLATING SYSTEM
K042235 · KWQ
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Sep 17, 2004
BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
K042251 · GKZ
Bayer Healthcare, LLC
Hematology · 28d
Cleared Sep 17, 2004
ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05
K042335 · JJY
Bio-Rad Laboratories, Inc.
Immunology · 18d
Cleared Sep 17, 2004
SCEPTREP3 PET/CT
K042428 · KPS
Hitachi Medical Systems America, Inc.
Radiology · 9d
Cleared Sep 16, 2004
MEDCOMP T-3
K033570 · NIE
Medcomp
Gastroenterology & Urology · 309d
Cleared Sep 16, 2004
ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND...
K033599 · HQD
The Lagado Corp.
Ophthalmic · 307d
Cleared Sep 16, 2004
RII INFRARED EAR THERMOMETER, MODELS THXXN SERIES
K040377 · FLL
Radiant Innovation, Inc.
General Hospital · 212d
Cleared Sep 16, 2004
DUET SYSTEM
K040591 · JOY
Bioview , Ltd.
Hematology · 192d
Cleared Sep 16, 2004
PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A
K040904 · NSA
Philips Medical Systems
Cardiovascular · 162d
Cleared Sep 16, 2004
RF INTRODUCTION CANNULA
K041021 · GXI
Epimed International, Inc.
Neurology · 149d
Cleared Sep 16, 2004
MAXITEX LATEX NEURO PF SURGICAL GLOVE POWDERFREE
K041437 · KGO
Terang Nusa Sdn Bhd
General Hospital · 111d
Cleared Sep 16, 2004
LSC LIFESTAND COMPACT
K041535 · IPL
Lifestand
Physical Medicine · 100d
Cleared Sep 16, 2004
CORAL SPINAL SYSTEM
K041592 · KWP
Theken Surgical
Orthopedic · 94d
Cleared Sep 16, 2004
ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM
K041663 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Sep 16, 2004
COMPRESSION ANASTOMOSIS CLIP (CAC)
K041751 · FZP
Niti Medical Technologies , Ltd.
General & Plastic Surgery · 79d
Cleared Sep 16, 2004
ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE
K041822 · DKZ
ACON Laboratories, Inc.
Chemistry · 72d
Cleared Sep 16, 2004
SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.X
K041989 · KWQ
Sintea Biotech, Inc.
Orthopedic · 55d
Cleared Sep 16, 2004
ASPIREX - BONE MARROW ASPIRATE KIT
K041991 · FMF
Isotis Orthobiologics, Inc.
General Hospital · 55d