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
74161–74184 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 12, 2002
REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH
K023328 · FTL
Center For Biomaterials and Advanced...
General & Plastic Surgery · 69d
Cleared Dec 12, 2002
K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM)
K023770 · KWD
Kinetikos Medical, Inc.
Orthopedic · 30d
Cleared Dec 12, 2002
ERBE VIO ESU WITH ACCESSORIES, MODEL VIO 300 D
K023886 · GEI
Erbe USA, Inc.
General & Plastic Surgery · 21d
Cleared Dec 12, 2002
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES)
K023957 · IYN
Sonosite,Inc.
Radiology · 15d
Cleared Dec 12, 2002
MILLENNIUM SERIES MANUAL WHEELCHAIRS
K024030 · IOR
Evermed Corp.
Physical Medicine · 6d
Cleared Dec 11, 2002
NXSTAGE CARTRIDGE EXPRESS
K014152 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 358d
Cleared Dec 11, 2002
KSEA DEPLOYABLE CARDIOVASCULAR CLAMP
K014277 · DXC
KARL STORZ Endoscopy-America, Inc.
Cardiovascular · 349d
Cleared Dec 11, 2002
BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM
K021039 · KWQ
Depuyacromed
Orthopedic · 254d
Cleared Dec 11, 2002
ACUBEAM, SUPER NOVA, DIO
K022888 · ILY
Light Force Therapy, Inc.
Physical Medicine · 103d
Cleared Dec 11, 2002
HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS
K022928 · IYO
Hudson Diagnostic Imaging, LLC
Radiology · 98d
Cleared Dec 11, 2002
W.O.M. LASER U100
K023041 · GEX
W.O.M. World of Medicine AG
General & Plastic Surgery · 90d
Cleared Dec 11, 2002
PRESS-FIT HEAD RESURFACING DEVICE
K023188 · KXA
Biomet Orthopedics, Inc.
Orthopedic · 78d
Cleared Dec 11, 2002
SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE
K023232 · EFS
Smartpractice
Dental · 75d
Cleared Dec 11, 2002
T2 SUPRACONDYLAR NAIL SYSTEM
K023267 · HSB
Howmedica Osteonics Corp.
Orthopedic · 72d
Cleared Dec 11, 2002
ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
K023299 · MNI
Alphatec Mfg., Inc.
Orthopedic · 69d
Cleared Dec 11, 2002
BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30
K023330 · CIG
Diagnostic Chemicals , Ltd.
Chemistry · 68d
Cleared Dec 11, 2002
COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION...
K023379 · MQF
Cooper Surgical
Obstetrics & Gynecology · 64d
Cleared Dec 11, 2002
PORTADUR P2
K023395 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 63d
Cleared Dec 11, 2002
ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY
K023597 · LTK
Beckman Coulter, Inc.
Immunology · 44d
Cleared Dec 11, 2002
ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 123, 133, 153,...
K023777 · HRX
Arthronet Medical, Inc.
Orthopedic · 29d
Cleared Dec 11, 2002
MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS
K023803 · DTB
Biotronik, Inc.
Cardiovascular · 27d
Cleared Dec 11, 2002
CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER
K023880 · DWF
Ethicon, Inc.
Cardiovascular · 20d
Cleared Dec 11, 2002
SENOCOR 360 CIRCUMFERENTIAL VACUUM ASSISTED BIOPSY DEVICE, 8 GAUGE
K023923 · KNW
Senorx, Inc.
Gastroenterology & Urology · 16d
Cleared Dec 11, 2002
MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS...
K023928 · JJW
Medical Analysis Systems, Inc.
Chemistry · 16d