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
53857–53880 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 2009
QUIKCLOT INTEVENTIONAL, MODEL P/N 182
K090620 · QSY
Z-Medica Corporation
General & Plastic Surgery · 30d
Cleared Apr 08, 2009
ELECTRONIC HOUSE CALL
K090801 · DRG
Express MD Solutions, LLC
Cardiovascular · 15d
Cleared Apr 07, 2009
PORTABLE OXYGEN UNIT SCA900
K080243 · CAN
San Cheong Co. , Ltd.
Anesthesiology · 432d
Cleared Apr 07, 2009
EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG)
K082130 · MOB
Euroimmun Us, Inc.
Immunology · 252d
Cleared Apr 07, 2009
VERTIGONE BPPV GOGGLE
K082634 · LXV
Vertigone, Inc.
Ear, Nose, Throat · 209d
Cleared Apr 07, 2009
LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X
K082679 · JEC
Sintea Biotech, Inc.
Orthopedic · 204d
Cleared Apr 07, 2009
VERSAFIT CUP DOUBLE MOBILITY SYSTEM
K083116 · MEH
Medacta International S.A.
Orthopedic · 168d
Cleared Apr 07, 2009
LANX SPINAL FIXATION SYSTEM
K083581 · MNH
Lanx, Inc.
Orthopedic · 124d
Cleared CT Apr 07, 2009
WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510,...
K083627 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 120d
Cleared Apr 07, 2009
CREATININE
K083809 · CGX
Abbott Laboratories
Chemistry · 106d
Cleared Apr 07, 2009
MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM
K090087 · FRN
Iradimed Corporation
General Hospital · 84d
Cleared Apr 07, 2009
MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEM
K090316 · KWQ
Lanx, Inc.
Orthopedic · 57d
Cleared Apr 07, 2009
FREEDOM METAL BACKED TIBIAL COMPONENT
K090411 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 48d
Cleared Apr 07, 2009
HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT...
K090723 · NHA
Zimmer Dental, Inc.
Dental · 29d
Cleared Apr 07, 2009
YIELD TISSUE SAMPLER
K090853 · EOQ
Broncus Technologies, Inc.
Ear, Nose, Throat · 8d
Cleared Apr 06, 2009
SPINNING SPIROS, MODEL CH-2000
K082806 · FPA
Icu Medical, Inc.
General Hospital · 194d
Cleared Apr 06, 2009
CARESTREAM DRX-1 SYSTEM
K090318 · MQB
Carestream Health, Inc.
Radiology · 56d
Cleared Apr 03, 2009
LIGHTSTREAM LOW LEVEL LASER
K081166 · NHN
Solica Corporation
Physical Medicine · 344d
Cleared Apr 03, 2009
INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C
K082327 · MUD
Somanetics Corp.
Cardiovascular · 232d
Cleared Apr 03, 2009
SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER...
K082470 · KJJ
Inter-Med, Inc.
Dental · 219d
Cleared Apr 03, 2009
APK SPO2 PULSE OXIMETER SENSOR
K082846 · DQA
APK Technology Co., Ltd.
Anesthesiology · 186d
Cleared Apr 03, 2009
MD2000A VITAL SIGN MONITOR, MODEL MD2000A
K083466 · DQA
Beijing Choice Electronic Technololgy...
Anesthesiology · 130d
Cleared Apr 03, 2009
INFANT CARDIAC ARRAY
K083539 · MOS
Advanced Imaging Research, Inc.
Radiology · 126d
Cleared Apr 03, 2009
MAK OSS KNEE FEMORAL COMPONENTS
K083779 · KRO
Biomet Manufacturing Corp
Orthopedic · 105d