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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
79201–79224 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 2001
LASERSKIN DRESSING
K001508 · MGP
Fidia Advanced Biopolymers Srl
General & Plastic Surgery · 436d
Cleared Jul 25, 2001
TACKER, MODEL R65-933
K003949 · OCW
A & A Medical, Inc.
Gastroenterology & Urology · 216d
Cleared Jul 25, 2001
DRAINAGE CATHETER OR FOLEY CATHETER
K010006 · EZL
Applied Medical Resources Corp.
Gastroenterology & Urology · 204d
Cleared Jul 25, 2001
TREMOROMETER
K010270 · GYD
Flexable Systems, Inc.
Neurology · 177d
Cleared Jul 25, 2001
LIPOPRINT SYSTEM, LDL SUBFRACTIONS
K010337 · JHO
Quantimetrix Corp.
Chemistry · 170d
Cleared Jul 25, 2001
MEDIFIX URETEROSCOPE
K011325 · FGB
Medifix, Inc.
Gastroenterology & Urology · 85d
Cleared Jul 25, 2001
HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
K011689 · LPS
Catch, Inc.
Chemistry · 55d
Cleared Jul 25, 2001
HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
K011692 · LPS
Intersect Systems, Inc.
Chemistry · 55d
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