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
64753–64776 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 2005
VASCULAR SOLUTIONS PRONTO V3 EXTRACTION CATHETER
K052232 · QEZ
Vascular Solutions, Inc.
Cardiovascular · 42d
Cleared Sep 28, 2005
MFCD 1219, MFCD 1219 TS
K052478 · LLZ
Barcoview
Radiology · 19d
Cleared Sep 28, 2005
FUSION CURING LIGHT
K052593 · EBZ
Dentlight, Inc.
Dental · 7d
Cleared Sep 28, 2005
LOW PROFILE PLATE AND SCREW SYSTEM
K052614 · HRS
Arthrex, Inc.
Orthopedic · 5d
Cleared Sep 27, 2005
E-POLY (VITAMIN E) ACETABULAR LINERS
K050327 · LPH
Biomet, Inc.
Orthopedic · 230d
Cleared Sep 27, 2005
B-CARE POWDER FREE LATEX EXAMINATION GLOVES
K051404 · LYY
B-Care Industries Co., Ltd.
General Hospital · 119d
Cleared Sep 27, 2005
EZ-JECT
K051667 · KZH
Indolor, Ltd.
General Hospital · 97d
Cleared Sep 27, 2005
ARTHREX TENODESIS FAMILY
K051726 · HWC
Arthrex, Inc.
Orthopedic · 91d
Cleared Sep 27, 2005
TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR
K051865 · MEG
Terumo Medical Corp.
General Hospital · 78d
Cleared Sep 27, 2005
PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF)
K051887 · CAW
Carleton Life Support Systems, Inc.
Anesthesiology · 77d
Cleared Sep 27, 2005
GE DATEX-OHMEDA ENGSTROM CARESTATION
K051895 · CBK
Datex-Ohmeda, Inc.
Anesthesiology · 76d
Cleared Sep 27, 2005
HHF1 MAGNETIC RESONANCE IMAGING SYSTEM
K052172 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 49d
Cleared Sep 27, 2005
LCR
K052235 · EMA
3M Company
Dental · 41d
Cleared Sep 27, 2005
DIGITAL HAND DYNAMOMETER, MODEL SH5003
K052309 · LBB
Saehan Corp.
Neurology · 34d
Cleared Sep 27, 2005
THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)
K052422 · EAP
Flow X-Ray Corp.
Radiology · 25d
Cleared Sep 27, 2005
HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
K052434 · KPS
GE Medical Systems
Radiology · 21d
Cleared Sep 27, 2005
ACTIHEART
K052489 · GWK
Respironics, Inc.
Neurology · 15d
Cleared Sep 27, 2005
ACCOLADE RPS HIP STEM
K052542 · LZO
Stryker Orthopaedics
Orthopedic · 12d
Cleared Sep 27, 2005
PORTAL GRAVITY SYSTEM
K052579 · LNH
Portal, Inc.
Radiology · 7d
Cleared Sep 26, 2005
SYRYKER SORANO WHEELCHAIR
K051369 · IOR
Stryker Canada
Physical Medicine · 123d
Cleared Sep 26, 2005
HILT FAMILY LASER: HILT I, HILT II, HILT III
K051537 · ILY
Cynosure, Inc.
Physical Medicine · 108d
Cleared Sep 26, 2005
MATRIX HOLTER SYSTEM, MODEL M12
K051730 · MLO
Global Instrumentation, LLC
Cardiovascular · 91d
Cleared Sep 26, 2005
ACCOLADE HFX FEMORAL STEM
K051741 · LZO
Stryker Orthopaedics
Orthopedic · 90d
Cleared Sep 26, 2005
ASAHI TORNUS SUPPORT CATHETER
K051772 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 88d