FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
90601–90624 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 21, 1998
NURSE'S AID PATIENT ROTATION SYSTEM
K973624 · IOQ
Air Med Assist Products
Physical Medicine · 120d
Cleared Jan 21, 1998
MICROVASIVE LIPTHOTRIPSY PROBES
K973788 · FFK
Boston Scientific Corp
Gastroenterology & Urology · 107d
Cleared Jan 21, 1998
STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING
K974028 · MKO
Conceptus, Inc.
Obstetrics & Gynecology · 90d
Cleared Jan 21, 1998
CARPAL ENGAGING WRIST FUSION PLATE
K974030 · HRS
Terray Corp.
Orthopedic · 90d
Cleared Jan 21, 1998
0.9.% SODIUM CHLORIDE INHALATION SOLUTION, USP
K974056 · CAF
Holopack International, LP
Anesthesiology · 86d
Cleared Jan 21, 1998
KODAK DIGITAL SCIENCE QUALITY CONTROL WORKSTATION (QCW)
K974107 · LMD
Eastman Kodak Company
Radiology · 82d
Cleared Jan 21, 1998
STEALTHSTATION SYSTEM
K974187 · HAW
Surgical Navigation Technologies, Inc.
Neurology · 131d
Cleared Jan 21, 1998
REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE,...
K974312 · KNW
Telemed Systems, Inc.
Gastroenterology & Urology · 65d
Cleared Jan 20, 1998
MEDPOR OCULAR CONFORMER
K972034 · HQN
Porex Surgical, Inc.
Ophthalmic · 232d
Cleared Jan 20, 1998
FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED
K972385 · JOH
Smiths Industries Medical Systems, Inc.
Anesthesiology · 208d
Cleared Jan 20, 1998
TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI...
K972614 · CAW
Healthdyne Technologies, Inc.
Anesthesiology · 190d
Cleared Jan 20, 1998
WILSON-COOK 10 SHOT MULTI-BAND LIGATOR
K974018 · FHN
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 20, 1998
VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS.
K974077 · EHD
J. Morita USA, Inc.
Radiology · 83d
Cleared Jan 20, 1998
KODAK DIGITAL SCIENCE CARDIAC VIEWER
K974086 · LLZ
Eastman Kodak Company
Radiology · 83d
Cleared Jan 20, 1998
MILTRA IMAGING INC., IMAGE VAULT
K974102 · LMD
Mitra Imaging, Inc.
Radiology · 81d
Cleared Jan 20, 1998
ARGOSY PROGRAMMABLE ONQUE
K974242 · ESD
Argosy Electronics
Ear, Nose, Throat · 69d
Cleared Jan 20, 1998
KERATOME SYSTEM
K974243 · HMY
Insight Technologies Instruments, LLC
Ophthalmic · 69d
Cleared Jan 20, 1998
ALCON CONTACT LENS CASE
K974281 · LRX
Alcon Laboratories
Ophthalmic · 67d
Cleared Jan 20, 1998
DIGITAL TINNITUS MASKING SYSTEM
K974501 · KLW
Petroff Audio Technologies
Ear, Nose, Throat · 53d
Cleared Jan 20, 1998
HEWLETT-PACKARD M2605A VIRIDIA WAVE VIEWER
K974567 · MSX
Hewlett-Packard Co.
Cardiovascular · 46d
Cleared Jan 20, 1998
PHACOPAK
K974719 · HQC
Paradigm Medical Industries, Inc.
Ophthalmic · 33d
Cleared Jan 16, 1998
DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES PARALLEL PIN, DEPTH GAGE, AND...
K970572 · DZE
Implant Integration Systems, Inc.
Dental · 336d
Cleared Jan 16, 1998
EMBLA
K971813 · OLV
Ferguson Medical
Neurology · 245d
Cleared Jan 16, 1998
HOME CARE BEAD BED
K972176 · INX
Kinetic Concepts, Inc.
Physical Medicine · 221d