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
70873–70896 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 2003
PASSMED SPINAL SYSTEM
K032094 · KWP
Medicrea
Orthopedic · 130d
Cleared Nov 14, 2003
BARD DUAL LUMEN URETERAL CATHETER
K032521 · EYB
C.R. Bard, Inc.
Gastroenterology & Urology · 91d
Cleared Nov 14, 2003
SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES
K032543 · EIA
Sirona Dental Systems GmbH
Dental · 88d
Cleared Nov 14, 2003
PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV...
K032636 · HEB
Playtex Products, Inc.
Obstetrics & Gynecology · 79d
Cleared Nov 14, 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA GREEN COLOR
K032670 · LYZ
Kingswell International, Inc.
General Hospital · 77d
Cleared Nov 14, 2003
MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE
K032777 · FOZ
Nipro Medical Corp.
General Hospital · 67d
Cleared Nov 14, 2003
PASCAL DYNAMIC CONTOUR TONOMETER
K032967 · HKY
Smt Swiss Microtechnology AG
Ophthalmic · 52d
Cleared Nov 14, 2003
BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM
K033007 · KXT
Bayer Diagnostics Corp.
Chemistry · 49d
Cleared Nov 14, 2003
MOBILETTE XP AND MOBILETT XPHYBRID
K033238 · IZL
Siemens Medical Systems, Inc.
Radiology · 39d
Cleared Nov 14, 2003
DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS
K033329 · HSB
Depuy, Inc.
Orthopedic · 29d
Cleared Nov 14, 2003
SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B
K033333 · FGE
Aomori Olympus Co., Ltd.
Gastroenterology & Urology · 29d
Cleared Nov 14, 2003
MODIFICATION TO LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES
K033353 · MOS
Usa Instruments, Inc.
Radiology · 25d
Cleared Nov 14, 2003
CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000
K033358 · LIH
Surgitech, Inc.
Neurology · 25d
Cleared Nov 14, 2003
AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE
K033468 · DTM
Medtronic Perfusion Systems
Cardiovascular · 11d
Cleared Nov 13, 2003
COPC BAND
K021594 · MVA
Center For Orthotic and Prosthetic...
Neurology · 547d
Cleared Nov 13, 2003
POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE BROTHERS
K031170 · LYZ
Long First (Xiamen) Co., Ltd.
General Hospital · 213d
Cleared Nov 13, 2003
RAINBOW GT-4A PAIN RELIEF MACHINE
K031546 · GZJ
Sino-Us Information, Inc.
Neurology · 181d
Cleared Nov 13, 2003
DENTATUS OSCIOMAT
K031793 · DZH
Dentatus USA , Ltd.
Dental · 156d
Cleared Nov 13, 2003
NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR...
K032444 · LZC
Cardinalhealth
General Hospital · 97d
Cleared Nov 13, 2003
PROFILE BBL SYSTEM
K032460 · GEX
Sciton, Inc
General & Plastic Surgery · 94d
Cleared Nov 13, 2003
NUVASIVE MESH
K032476 · MQP
Nuvasive, Inc.
Orthopedic · 93d
Cleared Nov 13, 2003
ZOLL AUTOCLAVABLE INTERNAL HANDLES
K032691 · LDD
Zoll Medical Corp
Cardiovascular · 72d
Cleared Nov 13, 2003
ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM
K032744 · JCT
Alveolus, Inc.
General & Plastic Surgery · 70d
Cleared Nov 13, 2003
BLUE SAIL (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K032781 · LYZ
Zibo Blue Sail Plastic & Rubber...
General Hospital · 66d