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
163009–163032 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 13, 1981
IMPLANTAID LEAD INTRODUCER #319-10 & 12
K812502 · DYB
Intermedics, Inc.
Cardiovascular · 42d
Cleared Oct 13, 1981
CT/T 8800
K812509 · JAK
General Electric Co.
Radiology · 41d
Cleared Oct 13, 1981
CARDIAC PACING ELECTRODES
K812517 · LDF
Medics Instrument Corp.
Cardiovascular · 41d
Cleared Oct 13, 1981
TRANSDUCER DOME
K812530 · DRS
Biomeal Corp.
Cardiovascular · 41d
Cleared Oct 13, 1981
PRE-BYPASS FILTER
K812539 · KRJ
Gelman Sciences, Inc.
Cardiovascular · 40d
Cleared Oct 13, 1981
LATERAL ANGULATING FLUORO SUSPENSION SYS
K812561 · JAA
General Electric Co.
Radiology · 35d
Cleared Oct 13, 1981
SECTORTAC
K812606 · IYN
Echo Laboratories, Inc.
Radiology · 28d
Cleared Oct 13, 1981
POLYPHOS 500
K812616 · IZO
Siemens Corp.
Radiology · 28d
Cleared Oct 13, 1981
INFANT CARIDAC MONITOR
K812674 · DRT
Electromed Intl., Ltd.
Cardiovascular · 21d
Cleared Oct 13, 1981
DISPOSABLE SURGICAL FACE MASKS
K812675 · FXX
Irema USA , Ltd.
General Hospital · 21d
Cleared Oct 13, 1981
AMPLITONE-3
K812676 · LDE
Progressive Technology, Inc.
Cardiovascular · 21d
Cleared Oct 13, 1981
NEONATE FLEXFLOAT
K812683 · FOH
Pharmaquest Corp.
General Hospital · 21d
Cleared Oct 13, 1981
LIF-O-GEN #3000 OXYGEN CONCENTRATOR
K812693 · CAW
Lif-O-Gen, Inc.
Anesthesiology · 15d
Cleared Oct 13, 1981
DISK
K812695
American Heartline, Inc.
Cardiovascular · 21d
Cleared Oct 13, 1981
ORTHO-THERM INFRARED SENSOR
K812701 · IYM
Orthion Corp.
Radiology · 20d
Cleared Oct 13, 1981
TECA #TE 8
K812715 · IKN
Teca, Inc.
Neurology · 18d
Cleared Oct 13, 1981
PEARCE CORNEAL TREPHINE
K812723 · HRH
Visitec Co.
Ophthalmic · 15d
Cleared Oct 09, 1981
MDM ARTERIAL BLOOD GAS SYRINGE
K812560 · FMF
Martell Medical Products, Inc.
General Hospital · 31d
Cleared Oct 09, 1981
TOTAL CALCIUM REAGENT SET
K812835 · CIC
Anco Medical Reagents & Assoc.
Chemistry
Cleared Oct 09, 1981
LDH REAGENT SET
K812836 · CFH
Anco Medical Reagents & Assoc.
Chemistry
Cleared Oct 08, 1981
MEDTRONIC DUAL CHANNEL SPINAL CORD STIM
K812155 · GZB
Medtronic Vascular
Neurology · 71d
Cleared Oct 08, 1981
UTERINE ASPIRATION CURETTES(RIGID&FLEX)
K812426 · HHK
Medi-Spec
Obstetrics & Gynecology · 44d
Cleared Oct 08, 1981
TANARAMA
K812543 · FTC
Marketing Consultants of America
General & Plastic Surgery · 34d
Cleared Oct 08, 1981
SUNTANNING HOME UNIT
K812579 · FTC
Tannhut
General & Plastic Surgery · 28d