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
117841–117864 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 1992
LAPAROSCOPIC CHOLANGIOGRAM CATHETER KIT
K915506 · GCA
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 88d
Cleared Mar 06, 1992
MIRAGE COMPLETE KIT AND MIRAGE ABC KIT
K915511 · KLE
Mirage Dental Systems
Dental · 88d
Cleared Mar 06, 1992
MEDILENS-CS CORNEAL SHIELD
K915861 · MOE
Chiron Ophthalmics
Ophthalmic · 66d
Cleared Mar 06, 1992
SPECTACLE FRAMES
K920123 · HQZ
Po-Le Optiks
Ophthalmic · 56d
Cleared Mar 06, 1992
HEAD COIL GEOMETRIC DISTOR SPEC FOR VISTA HPQ SYST
K920199 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 51d
Cleared Mar 06, 1992
RANGEROLLER (MODIFIED)
K920325 · ITI
Excel Mobility Products, Inc.
Physical Medicine · 51d
Cleared Mar 06, 1992
KONICA DIRECT DIGITIZER KD-1000
K920558 · KPR
Konica Corp.
Radiology · 84d
Cleared Mar 05, 1992
ARTECH ARDENT IV - TYPE CLYLINDER IMPLANT
K911735 · DZE
Artech Corp.
Dental · 323d
Cleared Mar 05, 1992
SINGLE USE LEE ELECTRODE
K912046 · HGI
Aspen Labs
Obstetrics & Gynecology · 302d
Cleared Mar 05, 1992
MODEL 310GE-64: WHOLE VOLUME NECK COIL
K914209 · LNH
Medical Advances, Inc.
Radiology · 168d
Cleared Mar 05, 1992
MOBILE MRP-7000
K920159 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 51d
Cleared Mar 04, 1992
NGM FRAME
K911644 · CBQ
Datex Division Instrumentarium Corp.
Anesthesiology · 324d
Cleared Mar 04, 1992
NGM NIBP MODULE
K911645 · DXN
Datex Division Instrumentarium Corp.
Cardiovascular · 324d
Cleared Mar 04, 1992
FIRST CHOICE
K912580 · CGA
Polymer Technology Corp.
Chemistry · 266d
Cleared Mar 04, 1992
DISPOSABLE INTROSSEOUS INFUSION NEEDLES
K913258 · FMI
Cook, Inc.
General Hospital · 225d
Cleared Mar 04, 1992
ENZYGNOST TOXOPLASMOSIS/IGM
K913505 · LGD
Behring Diagnostics, Inc.
Microbiology · 210d
Cleared Mar 04, 1992
PANCRETEC PROVIDER(R) MODEL 5500 INFUS PUMP, MODIF
K913931 · FRN
Abbott Laboratories
General Hospital · 188d
Cleared Mar 04, 1992
PIONEER PRO-PUMP
K914220 · HHK
Pioneer Medical, Inc.
Obstetrics & Gynecology · 167d
Cleared Mar 04, 1992
PIONEER PRO-PUMP DUAL CONTROL
K914241 · HHK
Pioneer Medical, Inc.
Obstetrics & Gynecology · 163d
Cleared Mar 04, 1992
DAIG ELECTROPHYSIOLOGY CATHETER W/INFUSION LUMEN
K914278 · DRF
Daig Corp.
Cardiovascular · 162d
Cleared Mar 04, 1992
OPTICAL CATHETER INTRODUCER SETS, MODIFICATION
K914315 · KGX
Medical Dynamics, Inc.
General & Plastic Surgery · 181d
Cleared Mar 04, 1992
ELISA CMV IGM
K914789 · LKQ
Sclavo, Inc.
Microbiology · 133d
Cleared Mar 04, 1992
GEMSCOM SERIES 3000
K914889 · DRG
General Devices
Cardiovascular · 125d
Cleared Mar 04, 1992
CLOSTRIDIUM DIFFICILE TOX-A-TEST
K914902 · LLH
Techlab, Inc.
Microbiology · 124d