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
79753–79776 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 01, 2001
TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018
K002042 · HGI
New England Medical Corp.
Obstetrics & Gynecology · 211d
Cleared Feb 01, 2001
PERSONAL GLUCOSE CONTROL CHARTING SYSTEM
K002688 · CGA
Lxn Corp.
Chemistry · 156d
Cleared Feb 01, 2001
CLIRANS E-SERIES HOLLOW FIBER DIALYZERS
K003425 · KDI
Terumo Medical Corp.
Gastroenterology & Urology · 90d
Cleared Feb 01, 2001
SUCTION IRRIGATOR
K003443 · FHF
Applied Medical
Gastroenterology & Urology · 87d
Cleared Feb 01, 2001
BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE
K003461 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 86d
Cleared Feb 01, 2001
PROCLUDE-SENSITIVE
K003482 · LBH
Ortek Therapeutics, Inc.
Dental · 84d
Cleared Feb 01, 2001
STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS
K003615 · FKP
Environmental Test Systems, Inc.
Gastroenterology & Urology · 71d
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