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
50809–50832 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 26, 2010
INFILTRATION KIT
K100062 · EBC
Dmg USA, Inc.
Dental · 74d
Cleared Mar 26, 2010
HOVEROUND TEKNIQUE, MODEL HD-6
K100527 · ITI
Hoveround Corp.
Physical Medicine · 30d
Cleared Mar 26, 2010
G-FORCE TI SUTURE ANCHOR SYSTEM
K100579 · MBI
Wrightmedicaltechnologyinc
Orthopedic · 24d
Cleared Mar 25, 2010
PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60
K091538 · CBP
Wet Nose Technologies, LLC
Anesthesiology · 303d
Cleared Mar 25, 2010
DBB-06 HEMODIALYSIS DELIVERY SYSTEM
K091978 · KDI
NIKKISO CO., LTD.
Gastroenterology & Urology · 267d
Cleared Mar 25, 2010
CODMAN STERILIZATION CONTAINERS
K092437 · KCT
Codman & Shurtleff, Inc.
General Hospital · 230d
Cleared Mar 25, 2010
MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519
K093406 · LJS
AngioDynamics, Inc.
General Hospital · 143d
Cleared Mar 25, 2010
FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT
K093831 · DXN
Health & Life Co., Ltd.
Cardiovascular · 101d
Cleared Mar 25, 2010
ETHICON ENDO SURGERY SLOTTED ANOSCOPE
K093896 · FER
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 97d
Cleared Mar 25, 2010
RAISIN PERSONAL MONITOR
K093976 · DXH
Proteus Biomedical, Inc.
Cardiovascular · 91d
Cleared Mar 25, 2010
CERAMIR CROWN & BRIDGE
K100510 · EMA
Doxa AB
Dental · 31d
Cleared Mar 24, 2010
EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT
K091890 · MED
Healthpoint, Ltd.
General Hospital · 274d
Cleared Mar 24, 2010
BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY
K092046 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 261d
Cleared Mar 24, 2010
BONASTENT BILIARY
K093003 · FGE
Endochoice, Inc.
Gastroenterology & Urology · 177d
Cleared Mar 24, 2010
INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE
K093808 · OVD
Incite Innovation, LLC
Orthopedic · 103d
Cleared Mar 24, 2010
PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01
K093984 · LNH
Time Medical Limited
Radiology · 90d
Cleared Mar 24, 2010
MULTIPLE PRIVATE LABEL
K100162 · LZA
Biogreen Yields Sdn.Bhd
General Hospital · 63d
Cleared Mar 24, 2010
MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM
K100186 · IYN
Medison Co., Ltd.
Radiology · 61d
Cleared Mar 24, 2010
GYNCARE MORCELLEX TISSUE MORCELLATOR
K100280 · HET
Ethicon, Inc.
Obstetrics & Gynecology · 51d
Cleared Mar 24, 2010
DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO
K100317 · MUH
VATECH Co., Ltd.
Radiology · 48d
Cleared Mar 24, 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K100326 · LYZ
Tangshan Hongda Plastci Products Co,...
General Hospital · 48d
Cleared Mar 24, 2010
NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP
K100385 · HGX
Luv N' Care, Ltd.
Obstetrics & Gynecology · 36d
Cleared Mar 24, 2010
XRES BLOOD COLLECTION RESERVOIR
K100507 · DTN
Sorin Group Italia S.R.L.
Cardiovascular · 30d
Cleared Mar 23, 2010
ROTEM DELTA THROMBOELASTOMETRY SYSTEM
K083842 · JPA
Pentapharm GmbH
Hematology · 454d