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
41761–41784 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 18, 2013
URGOCLEAN ABSORBENT WOUND DRESSING
K123219 · FRO
Laboratoires Urgo
General & Plastic Surgery · 154d
Cleared Mar 18, 2013
JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS...
K123485 · MBI
Biomet Sports Medicine
Orthopedic · 125d
Cleared Mar 18, 2013
3M ATTEST(TM) AUTO-READER
K123546 · FRC
3M Company
General Hospital · 119d
Cleared Mar 18, 2013
STERILE LATEX SURGICAL GLOVE
K123628 · KGO
Lucenxia Prescience AG
General Hospital · 115d
Cleared Mar 18, 2013
LANX FUSION SYSTEM- SA
K123767 · OVD
Lanx, Inc.
Orthopedic · 101d
Cleared Mar 18, 2013
ACUMED CANNULATED SCREW SYSTEM
K123890 · HWC
Acumed, LLC
Orthopedic · 90d
Cleared Mar 15, 2013
ULTRASONIC NEBULIZER (MESH TYPE)
K121520 · CAF
K-Jump Health Co., Ltd.
Anesthesiology · 297d
Cleared Mar 15, 2013
3M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE PACK 3M ATTEST(TM) SUPER...
K121593 · FRC
3M Company
General Hospital · 288d
Cleared Mar 15, 2013
X-FIX DYNAMIC EXTERNAL DISTRACTOR
K122415 · HTY
Arex USA, LLC
Orthopedic · 219d
Cleared Mar 15, 2013
RAYSCAN A-EXPERT
K122918 · MUH
Ray Co., Ltd.
Radiology · 172d
Cleared Mar 15, 2013
GALILEOS FAMILY
K123070 · OAS
Sirona Dental Systems GmbH
Radiology · 165d
Cleared Mar 15, 2013
TVC IMAGING SYSTEM MODEL NIRS-MC7-70
K123108 · OGZ
Infraredx, Inc.
Cardiovascular · 163d
Cleared Mar 15, 2013
BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60
K123225 · LOD
Aap Biomaterials GmbH & Co. KG
Orthopedic · 151d
Cleared Mar 15, 2013
FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING
K123298 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 143d
Cleared Mar 15, 2013
SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
K130138 · NBW
Roche Diagnostics Corp.
Chemistry · 56d
Cleared Mar 15, 2013
FLIXENE IFG VASCULAR GRAFT
K130142 · DSY
Atrium Medical Corporation
Cardiovascular · 52d
Cleared Mar 15, 2013
MEDELA THOPAZ
K130210 · BTA
Medela AG
General & Plastic Surgery · 45d
Cleared Mar 15, 2013
RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK...
K130236 · JJS
Radiometer Medical Aps
Chemistry · 44d
Cleared Mar 14, 2013
STA- COAG CONTROL (N+ABN) PLUS
K120014 · GGN
Diagnostica Stago, Inc.
Hematology · 441d
Cleared Mar 14, 2013
NIDEK RS-3000
K121622 · OBO
Nidek Co., Ltd.
Ophthalmic · 286d
Cleared Mar 14, 2013
FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS
K121747 · BZD
Intersurgical Incorporated
Anesthesiology · 273d
Cleared Mar 14, 2013
NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD...
K121933 · MSD
Marvao Medical Devices, Ltd.
Gastroenterology & Urology · 255d
Cleared Mar 14, 2013
IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL
K122534 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 206d
Cleared Mar 14, 2013
FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER
K122907 · LCX
Polymed Therapeutics, Inc.
Chemistry · 174d