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
141169–141192 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 1987
EASY-TEST TRIGLYCERIDE (TRIG) NUMBER 16608
K870408 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Mar 04, 1987
THE EQUALIZER AIRWAY DEVICE
K870501 · LQZ
Sleep Renewal, Inc.
Dental · 28d
Cleared Mar 04, 1987
TEFLON UTERINE SOUND
K870550 · HHM
Cook Ob/Gyn
Obstetrics & Gynecology · 22d
Cleared Mar 04, 1987
COSMEDTECH CANNULA
K870560 · HHI
Cosmedtech, Inc.
Obstetrics & Gynecology · 22d
Cleared Mar 04, 1987
EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95
K870571 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 22d
Cleared Mar 04, 1987
D. FARINAE ALLERGEN DISC
K870597 · DHB
Incstar Corp.
Immunology · 21d
Cleared Mar 04, 1987
HUNTLEIGH BETA II HM85
K870681 · FNM
Huntleigh Technology, Inc.
General Hospital · 13d
Cleared Mar 04, 1987
SMALL MASTOID RETRACTOR
K870758 · KAL
Treace Medical, Inc.
Ear, Nose, Throat · 6d
Cleared Mar 03, 1987
DUAL PHOTON BONE DENSITOMETER
K861233 · KGI
Medical and Scientific Enterprises, Inc.
Radiology · 336d
Cleared Mar 03, 1987
SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER
K863342 · DWF
Angiomedics, Inc.
Cardiovascular · 187d
Cleared Mar 03, 1987
HZI CEEG/EP SYSTEM SOFTWARE (CEEG-SCAN)TM
K863783 · OLT
Hzi Research Center
Neurology · 158d
Cleared Mar 03, 1987
PLURIMUS CARDIAC EVALUATION SYSTEM
K864401 · DSI
Vivix Corp.
Cardiovascular · 117d
Cleared Mar 03, 1987
FRESENIUS ULTRAFLUX AV400, AV600
K864587 · KDI
Seratronics, Inc.
Gastroenterology & Urology · 102d
Cleared Mar 03, 1987
ETP 300 NON-INVASIVE EXTERNAL PACEMAKER
K864986 · DRO
Medac, Inc.
Cardiovascular · 71d
Cleared Mar 03, 1987
DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE
K864987 · DRO
Medac, Inc.
Cardiovascular · 71d
Cleared Mar 03, 1987
ETP 180E NON-INVASIVE EXTERNAL PACEMAKER
K864988 · DRO
Medac, Inc.
Cardiovascular · 71d
Cleared Mar 03, 1987
ETP 180A NON-INVASIVE EXTERNAL PACEMAKER
K864989 · DRO
Medac, Inc.
Cardiovascular · 71d
Cleared Mar 03, 1987
ASPIRATING NEEDLE, CATALOG CODE #12006
K865079 · DWF
Dlp, Inc.
Cardiovascular · 64d
Cleared Mar 03, 1987
AMICI XENON REBREATHING SYSTEM*
K865084 · IYT
Amici, Inc.
Radiology · 63d
Cleared Mar 03, 1987
MODEL PY...U UNIPOLAR & BIPOLAR PACING LEAD
K870034 · DTB
Oscor Medical Corp.
Cardiovascular · 57d
Cleared Mar 03, 1987
MICRO-EAR CANAL IN-THE-EAR HEARING AID
K870079 · ESD
Micro-Ear Hearing Center, Inc.
Ear, Nose, Throat · 54d
Cleared Mar 03, 1987
MICRO-EAR FULL-CONCHA IN-THE-EAR HEARING AID
K870080 · ESD
Micro-Ear Hearing Center, Inc.
Ear, Nose, Throat · 54d
Cleared Mar 03, 1987
MICRO-EAR LOW-PROFILE IN-THE-EAR HEARING AID
K870081 · ESD
Micro-Ear Hearing Center, Inc.
Ear, Nose, Throat · 54d
Cleared Mar 03, 1987
BIOCHEM MICROSPAN 1040 OXIMETER
K870163 · DQA
Biochem International, Inc.
Anesthesiology · 48d