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
78073–78096 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 2001
GSI AUDERA
K011135 · EWO
Nicolet Biomedical
Ear, Nose, Throat · 104d
Cleared Jul 26, 2001
RF-IVD WIRELESS DOSIMETER-MODEL 1133
K011332 · IYE
Sun Nuclear Corp.
Radiology · 85d
Cleared Jul 26, 2001
METRONIC SOFAMOR DANEK CEMENT RESTRICTOR
K011998 · JDK
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Jul 26, 2001
VIKING OPTIMA GUIDING CATHETER
K012002 · DQY
Guidant Corp.
Cardiovascular · 29d
Cleared Jul 26, 2001
MODIFICATION TO THERMAL ANGEL
K012031 · BSB
Estill Medical Technologies, Inc.
Hematology · 28d
Cleared Jul 26, 2001
THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMMER) AND...
K012095 · JWH
Implex Corp.
Orthopedic · 21d
Cleared Jul 26, 2001
TERATECH MODEL 2000 HANDHELD ULTRASOUND SYSTEM WITH DOPPLER AND HARMONIC...
K012191 · IYN
Teratech Corp.
Radiology · 13d
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