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
47281–47304 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 08, 2011
J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW...
K110883 · KNW
Busse Hospital Disposables
Gastroenterology & Urology · 70d
Cleared Jun 08, 2011
MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS
K111007 · NMD
Midwest Reprocessing Center, LLC
Cardiovascular · 58d
Cleared Jun 08, 2011
ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM...
K111111 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 49d
Cleared Jun 08, 2011
MULTIPURPOSE DRAINAGE CATHETER
K111315 · FGE
Navilyst Medical, Inc.
Gastroenterology & Urology · 29d
Cleared Jun 08, 2011
HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)
K111339 · JOX
Medtronic, Inc.
Hematology · 27d
Cleared Jun 08, 2011
EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE...
K111379 · KWS
Exactech, Inc.
Orthopedic · 22d
Cleared Jun 07, 2011
DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC
K103086 · EZD
Dynarex Corporation
Gastroenterology & Urology · 231d
Cleared Jun 07, 2011
ILLUMINATING SINUS SEEKER
K110158 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 139d
Cleared Jun 06, 2011
REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES
K101733 · GCJ
Sac, LLC Dba Pinnacle Medical Surgical
General Hospital · 350d
Cleared Jun 06, 2011
BLUE POWDERFREE NITRILE EXAMINATION GLOVE
K102623 · LZA
Pt. Medisafe Technologies
General Hospital · 266d
Cleared Jun 06, 2011
TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK...
K103210 · FRG
Advanced Sterilization Products
General Hospital · 217d
Cleared Jun 06, 2011
BEHIND EAR GENTLE TOUCH THERMOMETER
K103839 · FLL
Kaz, Inc.
General Hospital · 158d
Cleared Jun 06, 2011
TRUBLUE NASAL MASK
K110405 · BZD
Respironics, Inc.
Anesthesiology · 112d
Cleared Jun 06, 2011
K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE
K110527 · FMI
Terumo Europe N.V.
General Hospital · 102d
Cleared Jun 06, 2011
MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM
K110753 · EKX
Dentsply International, Inc.
Dental · 80d
Cleared Jun 06, 2011
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR
K110972 · LYZ
Ppp Medical and Safety Products...
General Hospital · 61d
Cleared Jun 06, 2011
CLEARTEMP
K111017 · EMA
Ultradent Products, Inc.
Dental · 55d
Cleared Jun 06, 2011
MINI VARIABLE SYSTEM
K111041 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 53d
Cleared Jun 03, 2011
IPLAN
K101627 · HAW
Brainlab AG
Neurology · 359d
Cleared Jun 03, 2011
OWL CANNULAE
K102566 · GXI
Diros Technology, Inc.
Neurology · 269d
Cleared Jun 03, 2011
AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40
K102614 · GXY
Bio-Medical Research, Ltd.
Neurology · 266d
Cleared Jun 03, 2011
CARDIO XP
K102767 · DPS
Bionet Co., Ltd.
Cardiovascular · 252d
Cleared Jun 03, 2011
ISTAND
K103266 · HLI
Optovue, Inc.
Ophthalmic · 211d
Cleared Jun 03, 2011
ORTHO EASY PIN
K110275 · OAT
Forestadent Bernhard Forster GmbH
Dental · 123d