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

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176,076 results
67657–67680 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 29, 2004
HDL-EX SEIKEN ASSAY KIT
K041090 · LBS
Denka Seiken Co., Ltd.
Chemistry · 186d
Cleared Oct 29, 2004
NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS
K041100 · MBH
Zimmer, Inc.
Orthopedic · 185d
Cleared Oct 29, 2004
IV ADMINISTRATION SETS WITH ULTRABLOCK UV-RESISTANT TUBING
K041490 · FPA
B.Braun Medical, Inc.
General Hospital · 147d
Cleared Oct 29, 2004
MAMMOTEST
K042095 · IZH
Fischer Imaging Corp.
Radiology · 87d
Cleared Oct 29, 2004
DIAZYME POTASSIUM ENZYMATIC ASSAY KIT
K042191 · MZV
Diazyme Laboratories
Chemistry · 78d
Cleared Oct 29, 2004
DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT
K042193 · LCP
Diazyme Laboratories
Chemistry · 78d
Cleared Oct 29, 2004
DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT
K042448 · JJX
General Atomics
Chemistry · 50d
Cleared Oct 29, 2004
TI - SCREW ANCHOR SP
K042460 · MBI
Arthrotek, Inc.
Orthopedic · 49d
Cleared Oct 29, 2004
INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS
K042480 · KGI
Hologic, Inc.
Radiology · 46d
Cleared Oct 29, 2004
TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH...
K042485 · NQD
Roche Diagnostics Corp.
Chemistry · 46d
Cleared Oct 29, 2004
PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES
K042598 · HRS
Zimmer, Inc.
Orthopedic · 36d
Cleared Oct 29, 2004
NCB PLATING SYSTEM
K042695 · HRS
Zimmer GmbH
Orthopedic · 29d
Cleared Oct 29, 2004
ON-BOARD IMAGER DEVICE
K042720 · IYE
Varian Medical Systems
Radiology · 28d
Cleared Oct 29, 2004
MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER
K042724 · GKZ
Beckman Coulter, Inc.
Hematology · 28d
Cleared Oct 29, 2004
QC-BEADS
K042750 · NRF
Bioscreen, Inc.
Hematology · 25d
Cleared Oct 29, 2004
ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE)
K042793 · OWB
Siemens Medi Cal Solutions, Inc.
Radiology · 22d
Cleared Oct 29, 2004
C-PET PLUS IMAGING SYSTEM
K042839 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 15d
Cleared Oct 29, 2004
AUTOSPECS
K042903 · KPS
Adac Laboratories
Radiology · 14d
Cleared Oct 28, 2004
KARATS MULTIPURPOSE SOLUTION
K031753 · LPN
Ciba Vision Corporation
Ophthalmic · 511d
Cleared Oct 28, 2004
BIO-CHEM ANALYZER, MODEL 100
K040750 · CEM
Clinical Analysis Corporation, Inc.
Chemistry · 219d
Cleared Oct 28, 2004
STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM
K041271 · DZE
Sterngold
Dental · 169d
Cleared Oct 28, 2004
BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR
K041478 · CGA
Becton Dickinson
Chemistry · 147d
Cleared Oct 28, 2004
C-BOOT
K041659 · JOW
C-Boot , Ltd.
Cardiovascular · 132d
Cleared Oct 28, 2004
VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR...
K042006 · LBS
Ortho-Clinical Diagnostics, Inc.
Chemistry · 94d