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
49129–49152 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 01, 2010
ELECSYS CA 125 II CALCHECK 5
K102086 · JJX
Roche Diagnostics
Immunology · 98d
Cleared Nov 01, 2010
VASCUCLEAR PRECISION BIPOLAR
K102983 · GEI
Sorin Group USA, Inc.
General & Plastic Surgery · 25d
Cleared Oct 29, 2010
INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER,...
K092451 · CAH
Intersurgical, Inc.
General Hospital · 445d
Cleared Oct 29, 2010
NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701
K092477 · OMC
Neurowave Systems, Inc.
Neurology · 443d
Cleared Oct 29, 2010
REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS
K092896 · DXT
Nemoto Kyorindo Co., Ltd.
Cardiovascular · 403d
Cleared Oct 29, 2010
MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS
K100589 · JSO
Bio-Rad
Microbiology · 241d
Cleared Oct 29, 2010
ARROWHEAD FIXATION DEVICE
K100926 · HTY
Arrow Products, Inc.
Orthopedic · 207d
Cleared Oct 29, 2010
WMI REPROCESSED DVT WRAP, WMI REPROCESSED THERMAL WRAP MODEL: RD-1000F,...
K101035 · JOW
Wmi Enterprises, LLC
Cardiovascular · 198d
Cleared Oct 29, 2010
BLADEVIEW
K101042 · KPR
Accogent, LLC
Radiology · 198d
Cleared Oct 29, 2010
ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL
K101305 · ORH
ARK Diagnostics, Inc.
Toxicology · 172d
Cleared Oct 29, 2010
SPEEDFIX SUTURE SYSTEM
K101437 · MBI
Arthrocare Corp.
Orthopedic · 158d
Cleared Oct 29, 2010
TI-CORE FLOW
K101504 · EMA
Essential Dental Systems, Inc.
Dental · 150d
Cleared Oct 29, 2010
GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE
K101540 · EBF
Novocol Inc. Dba Septodont and...
Dental · 148d
Cleared Oct 29, 2010
FDR IMAGE STITCHING OPTION
K101686 · KPR
Fujifilm Medical System U.S.A., Inc.
Radiology · 135d
Cleared Oct 29, 2010
FULACCESS MODEL 1.0
K101707 · LLZ
Fulcrum Medical, Inc.
Radiology · 134d
Cleared Oct 29, 2010
COMFORT RUBBER GLOVES IND.SDN.BHD.
K101917 · LYY
Comfort Rubber Gloves Industries Sdn....
General Hospital · 112d
Cleared Oct 29, 2010
TIGERPAW SYSTEM
K101961 · GDW
Laax, Inc.
General & Plastic Surgery · 109d
Cleared Oct 29, 2010
DIGITAL RETINAL CAMERA
K102013 · HKI
Canon Inc. -Medical Equipment Group
Ophthalmic · 105d
Cleared Oct 29, 2010
3M INTEGRATED CYCLER (110V) & (220V)
K102314 · OOI
Focus Diagnostics, Inc.
Microbiology · 74d
Cleared Oct 29, 2010
GRANDTEC
K102347 · EBI
Voco GmbH
Dental · 71d
Cleared Oct 29, 2010
DEPUY PINNACLE ALTRX ACETABULAR LINERS
K102423 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 65d
Cleared Oct 29, 2010
ORTHO MTA (MINERAL TRIOXIDE AGGREGATE)
K102575 · KIF
Do Co., Ltd.
Dental · 51d
Cleared Oct 29, 2010
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA (YELLOW, WHITE,...
K102655 · LYZ
Ever Light Plastic Products Co., Ltd.
General Hospital · 44d
Cleared Oct 29, 2010
ALL-BOUND 3
K102844 · KLE
Bisco, Inc.
Dental · 30d