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
48097–48120 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 02, 2011
LAGUNA PEDICLE SCREW SYSTEM
K103748 · NKB
Phygen, LLC
Orthopedic · 69d
Cleared Mar 02, 2011
SPAULDING IQ ELECTROCARDIOGRAPH
K110065 · DPS
Spaulding Clinical Research, LLC
Cardiovascular · 51d
Cleared Mar 02, 2011
PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM
K110456 · KZE
Pharmajet, Inc.
General Hospital · 14d
Cleared Mar 01, 2011
TROKAMED MORCELLATOR
K091010 · HET
Trokamed GmbH
Obstetrics & Gynecology · 691d
Cleared Mar 01, 2011
RANDOX ECSTASY (MDMA) ASSAY
K092275 · DKZ
Randox Laboratories, Ltd.
Chemistry · 581d
Cleared Mar 01, 2011
V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER
K101569 · DPS
Taidoc Technology Corporation
Cardiovascular · 270d
Cleared Mar 01, 2011
DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010
K101876 · DPS
Shenzhen Biocare Electronics Co., Ltd.
Cardiovascular · 238d
Cleared Mar 01, 2011
MSA HIP SYSTEM
K102172 · MEH
Global Manufacturing Technology
Orthopedic · 211d
Cleared Mar 01, 2011
STELLAR 150
K103167 · MNT
Resmed Germany, Inc.
Anesthesiology · 125d
Cleared Mar 01, 2011
THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES
K103647 · FER
Thd Spa
Gastroenterology & Urology · 78d
Cleared Feb 28, 2011
KYPHON XPEDE BONE CEMENT
K102397 · NDN
Medtronic
Orthopedic · 188d
Cleared Feb 28, 2011
CORIN BIOLOX DELTA FEMORAL HEADS
K103120 · LZO
Corin USA
Orthopedic · 129d
Cleared Feb 28, 2011
GENERAL DENISTRY MOTOR
K103399 · EKX
Aseptico, Inc.
Dental · 101d
Cleared Feb 28, 2011
LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
K103660 · ODP
Lanx, Inc.
Orthopedic · 75d
Cleared Feb 28, 2011
CURVED / STRAIGHT / MINI / HOOK SCISSOR TIP, DISSECTOR TIP, SURGICAL HANDLE
K103840 · GEI
Flexbar Machine Corp.
General & Plastic Surgery · 80d
Cleared Feb 28, 2011
VERTICOR K-WIRE SYSTEM
K110047 · HTY
Verticor, Ltd.
Orthopedic · 53d
Cleared Feb 28, 2011
VANGUARD ASYMMETRICAL PATELLAR COMPONENT
K110362 · JWH
Biomet Manufacturing Corp
Orthopedic · 20d
Cleared Feb 25, 2011
STERRAAD 100NX EXPRESS CYCLE TEST PACK
K092755 · FRC
Advanced Sterilization Products
General Hospital · 534d
Cleared Feb 25, 2011
ROCHE FLUDI METHAMPHETAMINE
K093884 · LAF
Roche Diagnostics
Toxicology · 434d
Cleared Feb 25, 2011
FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815
K100799 · DYB
Contract Medical Intl. GmbH
Cardiovascular · 340d
Cleared Feb 25, 2011
ADAPT, MODEL AX-03SN
K100954 · OUM
Apeliotus Vision Science, Inc.
Ophthalmic · 324d
Cleared Feb 25, 2011
CHALLENGE-EVER
K102223 · EIA
Hallim Dentech Co., Ltd.
Dental · 203d
Cleared Feb 25, 2011
LUCIA
K102375 · ILY
Meridian Co., Ltd.
Physical Medicine · 189d
Cleared Feb 25, 2011
FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM
K102482 · LIT
Ostial Corporation
Cardiovascular · 179d