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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
78601–78624 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 2001
BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED...
K011718 · MVN
Bausch & Lomb, Inc.
Ophthalmic · 51d
Cleared Jul 25, 2001
K-ASSAY C1-INA
K011780 · DBA
Kamiya Biomedical Co.
Immunology · 48d
Cleared Jul 25, 2001
XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
K011869 · EOB
The Olympus Optical Co.
Ear, Nose, Throat · 41d
Cleared Jul 25, 2001
STREERABLE PTCA GUIDEWIRE
K011968 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 30d
Cleared Jul 25, 2001
EBI XFIX DFS SYSTEM
K012024 · KTT
Ebi, L.P.
Orthopedic · 27d
Cleared Jul 25, 2001
RAPID DRUG SCREEN
K012159 · DKZ
American Bio Medica Corp.
Toxicology · 33d
Cleared Jul 24, 2001
VACUUM ASSISTED CORE BIOPSY DEVICE
K010400 · KNW
Promex, Inc.
Gastroenterology & Urology · 162d
Cleared Jul 24, 2001
LASER PERIPHERALS REUSABLE HOLMIUM FIBER
K011207 · GEX
Laser Peripherals, LLC
General & Plastic Surgery · 96d
Cleared Jul 24, 2001
INTUITIVE SURGICAL ULTRASONIC SHEARS
K011281 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 88d
Cleared Jul 24, 2001
MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEM
K011999 · MSX
Data Critical Corp.
Cardiovascular · 27d
Cleared Jul 24, 2001
MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM
K012005 · MSX
Data Critical Corp.
Cardiovascular · 27d
Cleared Jul 24, 2001
MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT
K012034 · BZD
Sensor Medics Corp.
Anesthesiology · 25d
Cleared Jul 24, 2001
MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS
K012171 · MSX
Visicu, Inc.
Cardiovascular · 12d
Cleared Jul 23, 2001
AV 800 VENTILATOR
K010317 · CBK
Penlon , Ltd.
Anesthesiology · 171d
Cleared Jul 23, 2001
PRIMA OXYGEN MONITOR
K010318 · CCL
Penlon , Ltd.
Anesthesiology · 171d
Cleared Jul 23, 2001
ISODAN
K010415 · KLE
Specialites Septodont
Dental · 161d
Cleared Jul 23, 2001
BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.
K011438 · LXB
Entific Medical Systems, Inc.
Ear, Nose, Throat · 74d
Cleared Jul 23, 2001
TOOTH SHADE RESIN MATERIAL
K011453 · EBF
Rite-Dent Manufacturing Corp.
Dental · 73d
Cleared Jul 23, 2001
RESTORE-X
K011520 · EMA
First Scientific Limited
Dental · 67d
Cleared Jul 23, 2001
TRI-FIX SPINAL FIXATION SYSTEM
K011830 · KWP
Endius, Inc.
Orthopedic · 41d
Cleared Jul 23, 2001
FRESENIUS C.A.T.S
K012178 · CAC
Fresenius Hemotechnology, Inc.
Anesthesiology · 11d
Cleared Jul 23, 2001
ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520,...
K012207 · BZD
Tiara Medical Systems, Inc.
Anesthesiology · 7d
Cleared Jul 22, 2001
HYSTEROSCOPES
K003802 · HIH
Global Endoscopy, Inc.
Obstetrics & Gynecology · 226d
Cleared Jul 22, 2001
GYNECOLOGICAL LAPAROSCOPES
K003805 · HET
Global Endoscopy, Inc.
Obstetrics & Gynecology · 226d