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
68497–68520 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 2004
55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL...
K041559 · MSD
Spire Biomedical, Inc.
Gastroenterology & Urology · 50d
Cleared Jul 30, 2004
CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEAR
K041700 · LPL
Cantor & Nissel , Ltd.
Ophthalmic · 38d
Cleared Jul 30, 2004
CERCON CERAM EXPRESS CERAMIC SYSTEM
K041707 · EIH
Dentsply Intl.
Dental · 37d
Cleared Jul 30, 2004
APEX MEDICAL CPAP MODEL 9S-003
K041828 · BZD
Apex Medical Corp.
Anesthesiology · 23d
Cleared Jul 30, 2004
ALOKA SSD-ALPHA 5 ULTRASOUND SYSTEM
K041916 · IYN
Aloka Co. Ltd USA
Radiology · 14d
Cleared Jul 30, 2004
ALLURA XPER FD10
K041949 · IZI
Philips Medical Systems North America...
Radiology · 10d
Cleared Jul 29, 2004
MERLIN E-MASK
K031397 · CBP
Merlin Medical Limited
Anesthesiology · 454d
Cleared Jul 29, 2004
NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING...
K031858 · GWG
Richard Wolf Medical Instruments Corp.
Neurology · 409d
Cleared Jul 29, 2004
MISTIC HUMIDIFICATION SYSTEM...
K033614 · HIF
Northgate Technologies, Inc.
Obstetrics & Gynecology · 255d
Cleared Jul 29, 2004
15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706
K040992 · MSD
Medcomp
Gastroenterology & Urology · 104d
Cleared Jul 29, 2004
CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
K041044 · JOH
Cook, Inc.
Anesthesiology · 98d
Cleared Jul 29, 2004
SUTURE ARROW
K041128 · MAI
Linvatec Corp.
Orthopedic · 90d
Cleared Jul 29, 2004
MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K041223 · CBK
Maquet Critical Care AB
Anesthesiology · 80d
Cleared Jul 29, 2004
DENTIUM CO., LTD. IMPLANTIUM
K041368 · DZE
Dentium Co., Ltd.
Dental · 66d
Cleared Jul 29, 2004
FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE),...
K041644 · DQA
Elekon Industries U.S.A., Inc.
Anesthesiology · 42d
Cleared Jul 29, 2004
PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C
K041664 · CAW
On Site Gas Systems, Inc.
Anesthesiology · 41d
Cleared Jul 29, 2004
LNCS OXIMETRY SENSORS
K041815 · DQA
Masimo Corp.
Anesthesiology · 23d
Cleared Jul 29, 2004
GEMINI PET/CT IMAGING SYSTEM
K041955 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 8d
Cleared Jul 28, 2004
QUATRO M FEMORAL COMPONENT
K033313 · LWJ
Whiteside Biomechanics, Inc.
Orthopedic · 287d
Cleared Jul 28, 2004
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE
K033463 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 271d
Cleared Jul 28, 2004
KAPP CUSTOM ULNAR HEAD WRIST IMPLANT
K033930 · KXE
Kapp Surgical Instrument, Inc.
Orthopedic · 223d
Cleared Jul 28, 2004
CERAGEM-C THERMAL ACUPRESSURE MASSAGER
K040031 · JFB
Ceragem Co., Ltd.
Physical Medicine · 202d
Cleared Jul 28, 2004
PILLAR PALATAL IMPLANT SYSTEM
K040417 · LRK
Restore Medical, Inc.
Dental · 161d
Cleared Jul 28, 2004
SYNTHETIC VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
K040682 · LYZ
Grand Work Plastic Products Co., Ltd.
General Hospital · 134d