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
80281–80304 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 01, 2001
EEG WITH VIDEO, MODEL EX-NW
K010091 · GWQ
Excel Tech. , Ltd.
Neurology · 21d
Cleared Feb 01, 2001
MODIFICATION TO CAVERMAP SURGICAL AID
K010098 · FGM
Uromed Corp.
Gastroenterology & Urology · 21d
Cleared Feb 01, 2001
ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER
K010099 · LDF
Zcv ,Inc.
Cardiovascular · 21d
Cleared Feb 01, 2001
OCO DENTAL IMPLANT
K010142 · DZE
"O" Co., Inc.
Dental · 15d
Cleared Feb 01, 2001
BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER,...
K990284 · DXF
Baylis Medical Co., Inc.
Cardiovascular · 734d
Cleared Jan 31, 2001
LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES
K002445 · MKJ
Medtronic Physio-Control Corp.
Cardiovascular · 175d
Cleared Jan 31, 2001
VERTEX SYSTEM
K002822 · DPS
Medical Positioning, Inc.
Cardiovascular · 142d
Cleared Jan 31, 2001
EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM
K010003 · KWQ
Ebi, L.P.
Orthopedic · 29d
Cleared Jan 30, 2001
LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES AND ANCILLARY...
K002231 · FDS
Olympus Optical Co., Ltd.
Gastroenterology & Urology · 190d
Cleared Jan 30, 2001
APPALEAD GW+03XXXXXXR SERIES
K003394 · DQX
Nipro Medical Corp.
Cardiovascular · 90d
Cleared Jan 30, 2001
CT PERFUSION 2
K010042 · JAK
General Electric Co.
Radiology · 25d
Cleared Jan 29, 2001
BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520
K001543 · DXN
Welch Allyn, Inc.
Cardiovascular · 257d
Cleared Jan 29, 2001
STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE
K002273 · DWF
Stoeckert Instrumente
Cardiovascular · 187d
Cleared Jan 29, 2001
LIQUIDERM LIQUID ADHESIVE BANDAGE
K002338 · KMF
Closure Medical Corp.
General & Plastic Surgery · 181d
Cleared Jan 29, 2001
NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM
K002791 · DXN
Unix Electronic Co. , Ltd.
Cardiovascular · 144d
Cleared Jan 29, 2001
BIOTEQUE VAGINAL DILATOR
K003380 · HDX
Bioteque America, Inc.
Obstetrics & Gynecology · 90d
Cleared Jan 29, 2001
COLLES C SERIES FRAME STERILE PACK
K003397 · KTT
DePuy Orthopaedics, Inc.
Orthopedic · 89d
Cleared Jan 29, 2001
CHASE CARDIOVASCULAR PATCH
K003467 · DXZ
Chase Medical, Inc.
Cardiovascular · 82d
Cleared Jan 29, 2001
YASARGIL PERMANENT ANEURYSM CLIPS
K003519 · HCH
Aesculap, Inc.
Neurology · 75d
Cleared Jan 29, 2001
STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT
K003577 · FST
STERIS Corporation
General & Plastic Surgery · 70d
Cleared Jan 29, 2001
DIRECT BILIRUBIN
K003693 · CIG
Jas Diagnostics, Inc.
Chemistry · 60d
Cleared Jan 29, 2001
EPI-DERM SILICONE GEL SHEETING
K003948 · MDA
Biodermis Corp.
General & Plastic Surgery · 39d
Cleared Jan 29, 2001
GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FREE)
K010078 · LYY
Guthrie Medicare Products (Melaka)...
General Hospital · 19d
Cleared Jan 28, 2001
CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX
K003375 · LTZ
Tecnilatex S.A.
Obstetrics & Gynecology · 90d