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
56809–56832 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 2008
MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM
K080690 · KWQ
Theken Spine, LLC
Orthopedic · 45d
Cleared Apr 25, 2008
LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP
K080743 · FRN
Smiths Medical MD, Inc.
General Hospital · 39d
Cleared Apr 25, 2008
ACUSON X300 ULTRASOUND SYSTEM
K080760 · IYN
Siemens Medical Solutions USA, Inc.,...
Radiology · 38d
Cleared Apr 25, 2008
MODIFICATION TO VF GEL PLUS
K080956 · MIX
Coapt Systems, Inc.
Ear, Nose, Throat · 22d
Cleared Apr 25, 2008
SYNGO DYNAMICS VERSION 7.0
K081018 · LLZ
Siemens Medical Solutions
Radiology · 15d
Cleared Apr 25, 2008
SIGNA 3.0T MR750 SYSTEM
K081028 · LNH
Ge Medical Systems, LLC
Radiology · 14d
Cleared Apr 24, 2008
ERCHONIA EML LASER
K072206 · NHN
Erchonia Medical, Inc.
Physical Medicine · 260d
Cleared Apr 24, 2008
MEDDORNA WIRELESS PRN SPIROMETER 100
K072722 · BZG
Meddorna, LLC
Anesthesiology · 211d
Cleared Apr 24, 2008
TARGET STERILE ELECTRODE
K072799 · GXY
Vision Quest Industries, Inc.
Neurology · 206d
Cleared Apr 24, 2008
ZOLL E SERIES DEFIBRILLATOR
K072923 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 192d
Cleared Apr 24, 2008
CAPSTONE SPINAL SYSTEM
K073291 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 153d
Cleared Apr 24, 2008
FOUNDATION CAGE
K073440 · MAX
Corelink, LLC
Orthopedic · 139d
Cleared Apr 24, 2008
SURGI GLOVES
K073447 · KGO
Metacure Surgical Gloves Sdn Bhd
General Hospital · 139d
Cleared Apr 24, 2008
ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS
K073640 · LPS
Axis-Shield Diagnostics, Ltd.
Chemistry · 120d
Cleared Apr 24, 2008
SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701
K080005 · JCX
Ding Hwa Co., Ltd.
General & Plastic Surgery · 113d
Cleared Apr 24, 2008
SAFETY INFUSION SET
K080235 · FMI
Greiner Bio-One Vacuette North America
General Hospital · 85d
Cleared Apr 24, 2008
PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A
K080627 · FYA
Promedical Products Co., Ltd.
General Hospital · 50d
Cleared Apr 24, 2008
ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM
K080838 · ESW
Alveolus, Inc.
Gastroenterology & Urology · 30d
Cleared Apr 24, 2008
FAST1 INTRAOSSEOUS INFUSION SYSTEM
K080865 · FMI
Pyng Medical Corp.
General Hospital · 27d
Cleared Apr 24, 2008
CR-1
K080883 · HKI
Canon, Inc.
Ophthalmic · 24d
Cleared Apr 23, 2008
ANASEPT ANTIMICROBIAL SKIN AND WOUND CLEANSERS
K073547 · FRO
Anacapa Technologies, Inc.
General & Plastic Surgery · 127d
Cleared Apr 23, 2008
ELTA ADVANCED WOUND WASH
K073610 · FRO
Swiss American Products, Inc.
General & Plastic Surgery · 124d
Cleared Apr 23, 2008
ELIPO
K073715 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 114d
Cleared Apr 23, 2008
PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C
K080174 · LHI
Cardio Med Supplies, Inc.
General Hospital · 90d