FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
44161–44184 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 03, 2012
REPROCESSED FEMORAL COMPRESSION DEVICE
K120204 · NMF
Sterilmed, Inc.
Cardiovascular · 71d
Cleared Apr 03, 2012
RTVUE XR OCT
K120238 · HLI
Optovue, Inc.
Ophthalmic · 68d
Cleared Apr 03, 2012
HAMILTON-T1
K120670 · CBK
Hamilton Medical AG
Anesthesiology · 29d
Cleared Apr 03, 2012
ENCORE 26 ADVANTAGE KIT
K120694 · MAV
Boston Scientific Corp
Cardiovascular · 27d
Cleared Apr 02, 2012
HYBRID GRAFT
K111695 · FTL
Cook Biotech, Inc.
General & Plastic Surgery · 291d
Cleared Apr 02, 2012
A BAER WITH ABAER I/O FUNCTION
K112247 · EWO
Natus Medical Incorporated
Ear, Nose, Throat · 242d
Cleared Apr 02, 2012
XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES
K112426 · ETN
Xian Friendship Medical Electronics...
Ear, Nose, Throat · 223d
Cleared Apr 02, 2012
ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )
K112982 · HSB
Small Bone Innovations, Inc.
Orthopedic · 179d
Cleared Apr 02, 2012
ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS...
K113829 · JWH
Materialise NV
Orthopedic · 97d
Cleared Apr 02, 2012
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR
K120190 · LYZ
Rich Mountain Medical Products, Inc.
General Hospital · 70d
Cleared Apr 02, 2012
PENUMBRA COIL SYSTEM/PENUMBRA COIL 400
K120330 · HCG
Penumbra, Inc.
Neurology · 60d
Cleared Apr 02, 2012
CLEAR + BRILLIANT LASER SYSTEM
K120433 · ONG
Solta Medical, Inc.
General & Plastic Surgery · 49d
Cleared Apr 02, 2012
TIGER SPINE SYSTEM
K120696 · MNI
Corelink, LLC
Orthopedic · 26d
Cleared Apr 02, 2012
PATHASSIT LIGHT SEEKER
K120735 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 24d
Cleared Apr 02, 2012
ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLOC(TM) BONE SCREWS
K120802 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 17d
Cleared Mar 30, 2012
BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS
K103834 · MID
Bio-Rad Laboratories
Immunology · 456d
Cleared Mar 30, 2012
RESPIRATORY HUMIDIFER
K110019 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 452d
Cleared Mar 30, 2012
URETRON MODEL URT
K111058 · FFK
Med-Sonics Corp.
Gastroenterology & Urology · 347d
Cleared Mar 30, 2012
ATTUNE SLEEP APNEA SYSTEM
K111549 · OZR
Apnicure, Inc.
Anesthesiology · 301d
Cleared Mar 30, 2012
DIAZYME CYSTATIN C POC TEST KIT
K111664 · NDY
Diazyme Laboratories
Chemistry · 290d
Cleared Mar 30, 2012
CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R)...
K112119 · DTK
William Cook Europe Aps
Cardiovascular · 249d
Cleared Mar 30, 2012
ULTRA BEAUTY
K112351 · NFO
Johari Digital Healthcare , Ltd.
Neurology · 227d
Cleared Mar 30, 2012
ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS
K112452 · DQO
AngioDynamics, Inc.
Cardiovascular · 218d
Cleared Mar 30, 2012
DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES...
K113168 · LPL
Ciba Vision Corporation
Ophthalmic · 155d