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

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176,076 results
165265–165288 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 1981
LEKSELL STEREOTACTIC SYSTEM
K802140 · IWY
Downs Surgical , Ltd.
Radiology · 154d
Cleared Feb 05, 1981
IMPLANTABLE VENTRICULAR-INHIBITED CARDI
K802175
Telectronics, Inc.
Cardiovascular · 149d
Cleared Feb 05, 1981
SIEMENS-ELEMA PULSE GENERATOR 678
K802864 · DXY
Siemens Elema AB
Cardiovascular · 85d
Cleared Feb 05, 1981
SEBESTYEN IRRIGATING CONTACT LENS
K802927 · HJI
Cooper Medical Devices Corp.
Ophthalmic · 78d
Cleared Feb 05, 1981
LANDERS CONTACT LENS
K802971 · HJI
Cooper Medical Devices Corp.
Ophthalmic · 76d
Cleared Feb 05, 1981
CONPHAR EYE PROTECTOR
K803145 · HMP
Conphar, Inc.
General & Plastic Surgery · 55d
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