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
48073–48096 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 2011
BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR
K110145 · MBI
Biomet, Inc.
Orthopedic · 45d
Cleared Mar 04, 2011
OLECRA INTRAMEDULLARY FIXATION SYSTEM
K110322 · HSB
Mylad Orthopedic Solutions
Orthopedic · 29d
Cleared Mar 04, 2011
4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM
K110354 · JDP
Synthes (Usa)
Orthopedic · 25d
Cleared Mar 04, 2011
EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM
K110393 · GKR
Ekf Diagnostic GmbH
Hematology · 21d
Cleared Mar 03, 2011
MEDLINE ANGIOGRAPHIC CONTROL SYRINGE
K093830 · DXT
Medline Industries, Inc.
Cardiovascular · 444d
Cleared Mar 03, 2011
NON-STERILE, BLUE & WHITE POWDERED NITRILE EXAMINATION GLOVES
K101820 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 246d
Cleared Mar 03, 2011
RESTORATION ACETABULAR WEDGE AUGMENTS
K102019 · LPH
Howmedica Osteonics
Orthopedic · 227d
Cleared Mar 03, 2011
SAM CHEST SEAL WITH VAVLE
K102403 · NAD
Sam Medical Products
General & Plastic Surgery · 191d
Cleared Mar 03, 2011
AVITA SCANEO IR THERMOMETER MODEL TS4X SERIES
K102554 · FLL
Avita Corporation
General Hospital · 177d
Cleared Mar 03, 2011
VANGUARD REMOVABLE MOLDED POLY TIBIA
K102580 · JWH
Biomet Manufacturing Corp
Orthopedic · 176d
Cleared Mar 03, 2011
ZENITH PEDICLE SYSTEM
K102636 · MNH
Apollo Spine, Inc.
Orthopedic · 171d
Cleared Mar 03, 2011
INTERLOCK FIBERED IDC OCCLUSION SYSTEM
K102912 · KRD
Boston Scientific
Cardiovascular · 153d
Cleared Mar 03, 2011
TROPHON CHEMICAL INDICATOR
K103126 · JOJ
Nanosonics Limited
General Hospital · 132d
Cleared Mar 03, 2011
SPACELABS MULTI-PARAMETER MODULE
K103142 · DSI
Spacelabs Healthcare, Inc.
Cardiovascular · 129d
Cleared Mar 03, 2011
PERMOBIL M300 / M400
K103477 · ITI
Permobil AB
Physical Medicine · 97d
Cleared Mar 03, 2011
AXIS PACS, HMS PACS
K103679 · LLZ
Axis Health Care, LLC
Radiology · 76d
Cleared Mar 03, 2011
NUVASIVE TRAVERSE PLATE SYSTEM
K103750 · KWQ
Nuvasive, Inc.
Orthopedic · 70d
Cleared Mar 03, 2011
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K110295 · KRD
Boston Scientific Corp
Cardiovascular · 30d
Cleared Mar 02, 2011
SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION
K101850 · CBK
Spacelabs Healthcare, Ltd.
Anesthesiology · 244d
Cleared Mar 02, 2011
BLOOD PRESSURE CUFF
K102825 · DXQ
APK Technology Co., Ltd.
Cardiovascular · 154d
Cleared Mar 02, 2011
SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM
K103002 · HSB
Synthes (Usa)
Orthopedic · 145d
Cleared Mar 02, 2011
CONCORDE BULLET CAGE SYSTEM
K103488 · MAX
Johnson and Johnson
Orthopedic · 96d
Cleared Mar 02, 2011
INPECTRA STO2 SPOT CHECK
K103613 · MUD
Hutchinson Technology, Inc.
Cardiovascular · 83d
Cleared Mar 02, 2011
SURGISURE TISSUE REMOVAL SYSTEM
K103741 · GCJ
Interlace Medical, Inc.
General & Plastic Surgery · 69d