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
44449–44472 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 04, 2012
POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
K112797 · LIT
Cordis Corp.
Cardiovascular · 221d
Cleared May 04, 2012
KIMBERLY-CLARK CHILD'S FACEMASK
K113340 · OXZ
Kimberly-Clark
General Hospital · 172d
Cleared May 04, 2012
DUKAL LUBRICATING JELLY
K113689 · KMJ
Dukal Corporation
General Hospital · 141d
Cleared May 04, 2012
VIVIX-S
K120020 · MQB
Vieworks Co., Ltd.
Radiology · 122d
Cleared May 04, 2012
KENSEY NASH BONE VOID FILLER XC
K120141 · MQV
Kensey Nash Cororation
Orthopedic · 107d
Cleared May 04, 2012
ACCUSONIC ADVANTAGE
K120171 · IMI
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 105d
Cleared May 04, 2012
METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY
K120362 · LZO
Corin USA
Orthopedic · 88d
Cleared May 04, 2012
UNIMED DISPOSABLE BLOOD PRESSURE CUFF
K120364 · DXQ
Unimed Medical Supplies, Inc.
Cardiovascular · 88d
Cleared May 04, 2012
UNITED U2 FEMORAL COMPONENT, PS, #7
K120507 · JWH
United Orthopedic Corporation
Orthopedic · 73d
Cleared May 04, 2012
END TIDAL CO2 NASAL CANNULA
K120518 · CCK
Care Fusion
Anesthesiology · 73d
Cleared May 04, 2012
HLIC NEEDLE-LESS VALVE
K120548 · FPA
Health Line International Corporation
General Hospital · 71d
Cleared May 04, 2012
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
K121015 · NTE
Abbott Vascular
Cardiovascular · 30d
Cleared May 04, 2012
COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS
K121057 · DTK
William Cook Europe Aps
Cardiovascular · 28d
Cleared May 03, 2012
FORCE MEDICAL IM NAIL SYSTEM
K102577 · HSB
Force Medical, Inc.
Orthopedic · 603d
Cleared May 03, 2012
APTIMA COMBO 2 ASSAY
K111409 · LSL
Gen-Probe, Inc.
Microbiology · 350d
Cleared May 03, 2012
LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF...
K112083 · MQL
Intl., Inc.
Obstetrics & Gynecology · 287d
Cleared May 03, 2012
GEM PREMIER 4000
K112995 · CEM
Instrumentation Laboratory CO
Chemistry · 209d
Cleared May 03, 2012
RAPIDPOINT 500 BLOOD GAS ANALYER
K113216 · KHP
Siemens Healthcare Diagnostics
Chemistry · 184d
Cleared May 03, 2012
GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM
K113341 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 171d
Cleared May 03, 2012
COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL
K113660 · LKX
Cryotherapy Products, Inc.
Gastroenterology & Urology · 142d
Cleared May 03, 2012
ATAL-8
K113812 · MQB
Atlaim
Radiology · 132d
Cleared May 03, 2012
EMBRACE THERMOPLASTIC
K120335 · IYE
Bionix Development Corp.
Radiology · 90d
Cleared May 03, 2012
RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE
K120344 · JAQ
Radiadyne, LLC (Specification Developer)
Radiology · 90d
Cleared May 03, 2012
CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE...
K120351 · NBW
I-Sens, Inc.
Chemistry · 87d