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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
141409–141432 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 11, 1987
KODAK EKTASCAN IMAGE TRANSMISSION SYSTEM P1
K864739 · LLZ
Eastman Kodak Company
Radiology · 69d
Cleared Feb 11, 1987
TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR*
K864835 · FCD
Eisai U.S.A., Inc.
Radiology · 64d
Cleared Feb 11, 1987
KODAK EKTASCAN IMAGE TRANS SYS T1/R1 SOFTWARE,1.10
K864927 · LLZ
Eastman Kodak Company
Radiology · 69d
Cleared Feb 11, 1987
SYNTRON BIORESEARCH MICROCHECK HCG PREGNANCY TEST
K865076 · JHI
Syntron Bioresearch, Inc.
Chemistry · 44d
Cleared Feb 11, 1987
MOBIL-AIR
K870064 · CAW
Roman Laboratories, Inc.
Anesthesiology · 71d
Cleared Feb 11, 1987
AMMONIA (AMON) TESTPACK, ITEM NO. 67689/95
K870143 · JIF
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Feb 11, 1987
EMIT QUINIDINE CALIBRATOR ITEM NO. 67631/93
K870247 · DLJ
Em Diagnostic Systems, Inc.
Chemistry · 21d
Cleared Feb 11, 1987
EUSEK-BUSH IN-BATH FILMING DEVICE (#MC-00186)
K870429 · JAA
The Mason Clinic
Radiology · 6d
Cleared Feb 10, 1987
OSTEO TITANIUM DENTAL IMPLANT
K862854 · DZE
Osteo Implant Corp.
Dental · 196d
Cleared Feb 10, 1987
BIRD 6400ST VOLUME VENTILATOR
K863228 · CBK
Bird Products Corp.
Anesthesiology · 173d
Cleared Feb 10, 1987
DATASCOPE BALLOON DILATATION CATHETER
K863608
Datascope Corp.
Cardiovascular · 147d
Cleared Feb 10, 1987
RT2800(115V)/H4008C AND RT2800(220/240V)/H4008CE
K863700 · ITX
General Electric Co.
Radiology · 140d
Cleared Feb 10, 1987
TAMPER HAMPER
K863872 · LPZ
Hydro-Med Products, Inc.
General Hospital · 130d
Cleared Feb 10, 1987
MULTILITH 3 MODELS 1350, 3350, 1370, 3370
K863898 · DXY
Ela Medical, Inc.
Cardiovascular · 126d
Cleared Feb 10, 1987
25 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGY
K864166 · LKW
Weck Surgical Systems
Neurology · 110d
Cleared Feb 10, 1987
SALTER LABS #4001 ORAL NASAL CO2 SAMPLING CANNULA
K864199 · CCK
Salter Labs
Anesthesiology · 106d
Cleared Feb 10, 1987
MEDIPORT II SINGLE LUM/PORT IMPLANT VASC ACS PORT
K864349 · LJT
C.R. Bard, Inc.
General Hospital · 98d
Cleared Feb 10, 1987
COLIN STBP-780 STRESS TEST BLOOD PRESSURE MONITOR
K864654 · DXN
Colin Medical Instruments Corp.
Cardiovascular · 74d
Cleared Feb 10, 1987
SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH
K864707 · ELM
Ivoclar USA, Inc.
Dental · 70d
Cleared Feb 10, 1987
IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL
K864709 · EBI
Ivoclar USA, Inc.
Dental · 70d
Cleared Feb 10, 1987
ISOSIT N
K864710 · EBF
Ivoclar USA, Inc.
Dental · 70d
Cleared Feb 10, 1987
MEDI-TRACE INFANT ELECTRODE
K864722 · DRX
Graphic Controls Corp.
Cardiovascular · 69d
Cleared Feb 10, 1987
HALL ORAL IMPLANT SYSTEM
K864734 · DZE
Hall Surgical, Division of Zimmer, Inc.
Dental · 68d
Cleared Feb 10, 1987
TELAMAT
K864749 · JAA
Comet Ltd. C/O Radiology Resources, Inc.
Radiology · 67d