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
58297–58320 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 2007
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING...
K070265 · GQN
Diagnostic Hybrids, Inc.
Microbiology · 268d
Cleared Oct 24, 2007
ESTECH PERCUTANEOUS INSERTION DILATOR KIT
K070749 · DRE
Coombs Medical Device Consulting
Cardiovascular · 219d
Cleared Oct 24, 2007
REALIZE GASTRIC CALIBRATION TUBE, MODELS GCT180, GCT360
K071764 · KNT
Obtech Medical Sarl
Gastroenterology & Urology · 117d
Cleared Oct 24, 2007
ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM
K072081 · KWP
Alphatec Spine, Inc.
Orthopedic · 86d
Cleared Oct 24, 2007
CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON
K072327 · MQV
Regeneration Technologies, Inc.
Orthopedic · 65d
Cleared Oct 24, 2007
CYBERWAND STERILE PADS, MODEL: CW-RBPBX
K072422 · FFK
Cybersonics, Inc.
Gastroenterology & Urology · 57d
Cleared Oct 24, 2007
MICROCHOICE DRILLS AND SAWS, MICROPOWER DRILLS AND SAWS, MICROPOWER ORALMAX...
K072706 · HRX
Conmed Linvatec
Orthopedic · 30d
Cleared Oct 24, 2007
APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM
K072826 · ITX
Toshiba America Medical Systems, In.C
Radiology · 21d
Cleared Oct 23, 2007
PRO QR (QUICK RELIEF) POWDER (FOR MINOR EXTERNAL BLEEDING FROM WOUNDS &...
K070520 · QSY
Biolife, LLC
General & Plastic Surgery · 242d
Cleared Oct 23, 2007
EXPANDING VASCULAR SHEATH
K070865 · DYB
Applied Medical
Cardiovascular · 208d
Cleared Oct 23, 2007
SYNTHES CHRONOS COMPOSITE
K071046 · MQV
Synthes (Usa)
Orthopedic · 193d
Cleared Oct 23, 2007
OLYMPUS DENTAL IMPLANT SYSTEM
K071070 · DZE
Keystone Dental, Inc.
Dental · 190d
Cleared Oct 23, 2007
BIOMET CABLE SYSTEM
K071271 · JDQ
Biomet Manufacturing, Inc.
Orthopedic · 169d
Cleared Oct 23, 2007
ZUMA
K071726 · MQP
Seaspine, Inc.
Orthopedic · 120d
Cleared Oct 23, 2007
MOSAIC DEVICES
K071833 · OVE
Spinal Elements, Inc.
Orthopedic · 112d
Cleared Oct 23, 2007
NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG
K072362 · DTZ
Novalung GmbH
Cardiovascular · 62d
Cleared Oct 23, 2007
ACTIVATOR V SPINAL ADJUSTING INSTRUMENT
K072519 · LXM
Activator Methods International, Ltd.
Physical Medicine · 46d
Cleared Oct 23, 2007
A-BSM BONE SUBSTITUTE MATERIAL
K072636 · MQV
Etex Corp.
Orthopedic · 35d
Cleared Oct 23, 2007
ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR
K072655 · KRH
Genesee Biomedical, Inc.
Cardiovascular · 33d
Cleared Oct 23, 2007
ASAHI PTCA GUIDE WIRE, FIELDER FC J, MODELS: AGP140001J, AGP140301J
K072705 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 29d
Cleared Oct 23, 2007
RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS
K072768 · DZE
Lifecore Biomedical, Inc.
Dental · 25d
Cleared Oct 23, 2007
FOX SV PTA CATHETER
K072824 · LIT
Abbott Laboratories
Cardiovascular · 21d
Cleared Oct 23, 2007
MODIFICATON TO: ARTHROCARE ARTHROWANDS
K072865 · GEI
Arthrocare Corp.
General & Plastic Surgery · 18d
Cleared Oct 22, 2007
QUANTRX FEMALE FERTILITY TEST
K070484 · NGA
Quantrx Biomedical Corporation
Chemistry · 244d