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

Filters: Cleared only ×
176,076 results
64057–64080 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 2005
C2000 AUTOMATED MANIFOLD KIT
K052744 · DXT
Acist Medical Systems, Inc.
Cardiovascular · 77d
Cleared Dec 16, 2005
MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM
K052799 · MAI
Bonutti Research, Inc.
Orthopedic · 74d
Cleared Dec 16, 2005
IGI-SYSTEM
K052840 · HAW
Denx Advanced Dental Systems
Neurology · 70d
Cleared Dec 16, 2005
B-CARE POWDERED LATEX EXAMINATION GLOVES
K052845 · OPE
B-Care Industries Co., Ltd.
General & Plastic Surgery · 70d
Cleared Dec 16, 2005
STRYKER CUSTOM TI IMPLANT
K052871 · GXN
Stryker Leibinger
Neurology · 66d
Cleared Dec 16, 2005
WARMING LIQUID PERSONAL LUBRICANT
K052974 · NUC
Pharmapac, LLC
Obstetrics & Gynecology · 53d
Cleared Dec 16, 2005
STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH...
K052990 · KWY
Biomet, Inc.
Orthopedic · 53d
Cleared Dec 16, 2005
DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR
K053090 · JFM
Beckman Coulter, Inc.
Chemistry · 44d
Cleared Dec 16, 2005
STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX
K053116 · DQY
Boston Scientific Corp
Cardiovascular · 39d
Cleared Dec 16, 2005
STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-XXXXXX
K053118 · DQY
Boston Scientific Corp
Cardiovascular · 39d
Cleared Dec 16, 2005
MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM
K053154 · IYN
Pie Medical
Radiology · 32d
Cleared Dec 16, 2005
ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST)
K053196 · NJV
Inverness Medical Innovations, Inc.
Chemistry · 30d
Cleared Dec 16, 2005
U-CLIP DEVICE, MODELS B140, B160 AND B180
K053252 · FZP
Medtronic Vascular
General & Plastic Surgery · 25d
Cleared Dec 16, 2005
3M TEGADERM SILVER (AG) MESH
K053256 · FRO
3M Company
General & Plastic Surgery · 24d
Cleared Dec 16, 2005
ARCHITECT B12 CALIBRATORS
K053330 · JIT
Abbott Laboratories
Chemistry · 15d
Cleared Dec 16, 2005
GE VOLUSON I
K053435 · IYN
General Electric Co.
Radiology · 7d
Cleared Dec 15, 2005
I-STAT CREATINE KINASE MB (CK-MB)
K051433 · MYT
I-Stat Corporation
Chemistry · 197d
Cleared Dec 15, 2005
NIPRO SUREFUSER AMBULATORY INFUSION PUMP
K051828 · MEB
Nipro Medical Corporation
General Hospital · 162d
Cleared Dec 15, 2005
SOLAR GI
K052338 · FFX
Medical Measurement Systems B.V.
Gastroenterology & Urology · 111d
Cleared Dec 15, 2005
MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS
K052606 · LPL
Marietta Vision
Ophthalmic · 84d
Cleared Dec 15, 2005
VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE
K052632 · LLZ
Vital Images, Inc.
Radiology · 80d
Cleared Dec 15, 2005
YUSHENG DISPOSABLE VAGINAL SPECULUM
K052912 · HIB
Zhejiang Yusheng Medical Instrument...
Obstetrics & Gynecology · 59d
Cleared Dec 15, 2005
DDRFORMULA AND DDRFORMULA PLUS
K052943 · KPR
Swissray Medical AG
Radiology · 56d
Cleared Dec 15, 2005
DS CASSETTE
K053173 · IXA
Konica Minolta Medical & Graphic, Inc.
Radiology · 31d