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
80881–80904 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 01, 2001
EYETECT TREMOR MONITOR UNIT (TMU)
K003644 · GWN
Eyetect, LLC
Neurology · 66d
Cleared Feb 01, 2001
KAPPA IMMAGE FREELITE KIT
K003669 · DFH
The Binding Site, Ltd.
Immunology · 65d
Cleared Feb 01, 2001
LAMBDA IMMAGE FREELITE KIT
K003671 · DEH
The Binding Site, Ltd.
Immunology · 65d
Cleared Feb 01, 2001
POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM...
K003737 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 59d
Cleared Feb 01, 2001
CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES
K003840 · FYD
I.C Medical, Inc.
General Hospital · 51d
Cleared Feb 01, 2001
FLEXTIME MAGNUM 360
K003930 · ELW
Heraeus Kulzer, Inc.
Dental · 43d
Cleared Feb 01, 2001
M2376A DEVICELINK SYSTEM
K010048 · MWI
Agilent Technologies, Inc.
Cardiovascular · 27d
Cleared Feb 01, 2001
UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450
K010056 · LKF
A & A Medical, Inc.
Obstetrics & Gynecology · 24d
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