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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
164425–164448 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 1981
EVOKED RESPONSE STIMULATORS
K803226 · GWK
Bio-Logic Systems Corp.
Neurology · 48d
Cleared Feb 05, 1981
ALOFT STERILIZATION WRAP
K803306 · FRG
American Hospital Supply Corp.
General Hospital · 37d
Cleared Feb 05, 1981
SAFEED EXTENSION TUBES
K810005 · FPK
Terumo Medical Corp.
General Hospital · 30d
Cleared Feb 05, 1981
PANJE VOICE PROSTHESIS
K810020 · EWL
Xomed, Inc.
Ear, Nose, Throat · 31d
Cleared Feb 05, 1981
CORDIS TEMPORATY CURVED ATRIAL LEAD
K810041 · LDF
Cordis Corp.
Cardiovascular · 29d
Cleared Feb 05, 1981
AUTOPHOR 128
K810047 · JBD
Gelman Sciences, Inc.
Chemistry · 24d
Cleared Feb 05, 1981
AIRWAYS-OROPHARYNGEAL
K810099 · CAE
American Hospital Supply Corp.
Anesthesiology · 22d
Cleared Feb 05, 1981
ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE
K810147 · BZT
Portex, Inc.
Anesthesiology · 15d
Cleared Feb 05, 1981
TONGUE CLEANER
K810149 · LCN
Agp, Inc.
Dental · 15d
Cleared Feb 05, 1981
DERMOTOPHYTE TEST MEDIUM
K810181 · JSJ
Troy Biologicals, Inc.
Microbiology · 14d
Cleared Feb 05, 1981
SYSTEM 84 COMPUTERIZED LUNG VOL. SPIROM
K810196 · BZC
Cardio Pulmonary Instruments
Anesthesiology · 13d
Cleared Feb 05, 1981
CORDIS MULTIFILAR PERVENOUS VENTRIC. LD
K810202 · DTB
Cordis Corp.
Cardiovascular · 13d
Cleared Feb 04, 1981
STAT-CRIT HEMATOCRIT MEASURING INSTRU
K802199 · GKF
United States Surgical, A Division of...
Hematology · 147d
Cleared Feb 04, 1981
SPEAKEASY COMMUN. SYSTEM-COMM. PROTHESIS
K802687 · ILQ
Intelligent Software Systems, Inc.
Physical Medicine · 98d
Cleared Feb 04, 1981
MICROSCOPE MODEL OM-P
K802903 · EPT
Jedmed Instrument Co.
General & Plastic Surgery · 79d
Cleared Feb 04, 1981
MICROSCOPE MODEL OM-U
K802904 · EPT
Jedmed Instrument Co.
General & Plastic Surgery · 79d
Cleared Feb 04, 1981
HITEMP. TM 2 LOOPTIP CAUTERY
K802942 · GEI
Medical Products Development, Inc.
General & Plastic Surgery · 77d
Cleared Feb 04, 1981
WILLIAM HARVEY VENTED MEDIASTINAL DRAIN
K803037 · DWM
C.R. Bard, Inc.
Anesthesiology · 65d
Cleared Feb 04, 1981
AUTOMATED PERIMETERS
K803159 · HPT
Coburn Optical Ind., Inc.
Ophthalmic · 58d
Cleared Feb 04, 1981
FISHER-PICKERING INTRAOCULAR EYE MAGNET
K803194 · HNR
Storz Instrument Co.
Ophthalmic · 50d
Cleared Feb 04, 1981
SYSTEM 1 INSTRUMENT STAND
K803195 · HMF
Surgical Mechanical Research, Inc.
Ophthalmic · 50d
Cleared Feb 04, 1981
GEO-TIBIAL RETAINER ROTATIONAL
K803235 · HSX
Zimmer, Inc.
Orthopedic · 44d
Cleared Feb 04, 1981
LL100 CRYOSURGICAL SYSTEM
K803311 · GEH
Wallach Surgical Devices, Inc.
General & Plastic Surgery · 33d
Cleared Feb 04, 1981
MICROMEDIC AUTOMATIC COMPUTING CENTER
K803312 · JQP
Micomedic Systems
Radiology · 33d