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
141073–141096 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 10, 1987
CARDIOMAX-II
K861543 · DXG
Columbus Instruments Intl. Corp.
Cardiovascular · 320d
Cleared Mar 10, 1987
DIMENSION-WBG
K863223 · CGA
Dimension Diagnostics
Chemistry · 201d
Cleared Mar 10, 1987
OCEAN SCIENTIFIC VDRL TEST
K864731 · GMQ
Ocean Scientific, Inc.
Microbiology · 96d
Cleared Mar 10, 1987
DIASONICS SPA 5.O 27MM PROBE
K864758 · ITX
Diasonics, Inc.
Radiology · 95d
Cleared Mar 10, 1987
DIASONICS SPA 3.5 MHZ, 30MM PROBE
K864812 · ITX
Diasonics, Inc.
Radiology · 91d
Cleared Mar 10, 1987
LIFESOUND(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTOR
K864858 · BZT
Biomedical Concepts, Inc.
Anesthesiology · 89d
Cleared Mar 10, 1987
SEGURA DRETLER BASKET
K864874 · FFL
Van-Tec, Inc.
Gastroenterology & Urology · 88d
Cleared Mar 10, 1987
BICARBONATE MIXING SYSTEM
K864942 · KPO
Morris Tool , Ltd.
Gastroenterology & Urology · 83d
Cleared Mar 10, 1987
TERUMO DENTAL NEEDLES
K864970 · DZM
Terumo Medical Corp.
Dental · 78d
Cleared Mar 10, 1987
DISPOS GEL EXTERNAL PACING ELECTRODE/LOW IMPEDANCE
K864985 · DRO
Medac, Inc.
Cardiovascular · 78d
Cleared Mar 10, 1987
CARDIOFAX-V ECG-8240A
K865030 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 77d
Cleared Mar 10, 1987
CARDIOFAX-V ECG-834OA
K865032 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 77d
Cleared Mar 10, 1987
TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY
K865057 · JHI
Hybritech, Inc.
Chemistry · 76d
Cleared Mar 10, 1987
WILLIAMS FLEXIBLE CYSTOSCOPIC INJECTION NEEDLE
K865086 · FBK
Van-Tec, Inc.
Gastroenterology & Urology · 70d
Cleared Mar 10, 1987
EXTERNAL Y VALVE 5C4198
K870145 · KDJ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 56d
Cleared Mar 10, 1987
DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST
K870155 · GTZ
Bd Becton Dickinson Vacutainer...
Microbiology · 56d
Cleared Mar 10, 1987
VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044
K870259 · JHI
Leeco Diagnostics, Inc.
Chemistry · 46d
Cleared Mar 10, 1987
EASY-TEST CREATINE KINASE-MB (CK-MB) #16615
K870462 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Mar 10, 1987
TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY
K870520 · CGJ
Hybritech, Inc.
Chemistry · 32d
Cleared Mar 10, 1987
VAN-TEC PEDIATRIC SUPRAPUBIC CATHETER SET
K870555 · KOB
Van-Tec, Inc.
Gastroenterology & Urology · 28d
Cleared Mar 10, 1987
VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SET
K870556 · KOB
Van-Tec, Inc.
Gastroenterology & Urology · 28d
Cleared Mar 10, 1987
VAN-TEC OPEN ENDED CONE TIP URETERAL CATHETER
K870694 · KOD
Van-Tec, Inc.
Gastroenterology & Urology · 19d
Cleared Mar 10, 1987
VAN-TEC URETHRAL DILATATION SYSTEM
K870695 · KOE
Van-Tec, Inc.
Gastroenterology & Urology · 19d
Cleared Mar 10, 1987
VAN-TEC ONE STEP URETERAL DILATATION CATHETER
K870697 · EZN
Van-Tec, Inc.
Gastroenterology & Urology · 19d