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
60697–60720 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 05, 2007
PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE
K063781 · LLZ
Philips Medical Systems North America...
Radiology · 15d
Cleared Jan 05, 2007
STEAMPLUS STEAM INTEGRATOR
K063799 · JOJ
Spsmedical Supply Corp.
General Hospital · 14d
Cleared Jan 05, 2007
ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM
K063803 · IYN
Siemens Medical Solutions USA, Inc.,...
Radiology · 14d
Cleared Jan 04, 2007
GAMBRO POSICLEAR
K061782 · FIP
Gambro Services, Inc.
Gastroenterology & Urology · 192d
Cleared Jan 04, 2007
GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND...
K062675 · GXY
Gemore Technology Co, Ltd.
Neurology · 118d
Cleared Jan 04, 2007
IKONISCOPE ONCOFISH BLADDER TEST SYSTEM
K062755 · JOY
Ikonisys, Inc.
Hematology · 112d
Cleared Jan 04, 2007
HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER
K063338 · EWO
Mimosa Acoustics, Inc.
Ear, Nose, Throat · 59d
Cleared Jan 04, 2007
DEPUY PEAK FX HIP PLATE
K063509 · KTT
DePuy Orthopaedics, Inc.
Orthopedic · 45d
Cleared Jan 04, 2007
ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5
K063559 · LNH
Philips Medical Systems
Radiology · 38d
Cleared Jan 04, 2007
TS-BONE HIP TOOL
K063709 · HRS
Orthopedic Sciences, Inc.
Orthopedic · 21d
Cleared Jan 04, 2007
ACUSON P10 DIAGNOSTIC ULTRASOUND SYSTEM
K063761 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Jan 03, 2007
LIFECELL DURAL SUBSTITUTE MATRIX
K061208 · GXQ
Lifecell Corp.
Neurology · 247d
Cleared Jan 03, 2007
BONART ART-L3 LED CURING LIGHT
K062289 · EBZ
Bonart Co., Ltd.
Dental · 149d
Cleared Jan 03, 2007
BIOTOP HOOKSAFE U-100 INSULIN SYRINGE, MODELS 0.5CC/ML AND 1CC/ML
K062318 · MEG
Biotop Technology Co., Ltd.
General Hospital · 147d
Cleared Jan 03, 2007
AR1000 ULTRASONIC WOUND THERAPY SYSTEM
K062544 · LFL
Arobella Medical, LLC
General & Plastic Surgery · 126d
Cleared Jan 03, 2007
V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS
K062896 · GEH
Sanarus Medical, Inc.
General & Plastic Surgery · 98d
Cleared Jan 03, 2007
LAPMAN LAPAROSCOPE MANIPULATOR AND ACCESSORIES, MODEL 900-200 SERIES
K062968 · GCJ
Medsys, S.A.
General & Plastic Surgery · 96d
Cleared Jan 03, 2007
ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS
K063058 · KWD
Arthrex, Inc.
Orthopedic · 90d
Cleared Jan 03, 2007
APEXNRG XFR
K063843 · LQY
Medicnrg , Ltd.
Dental · 8d
Cleared Dec 29, 2006
ELIA CELIKEY IGA WELL, MODEL 14-5517-01
K062787 · MVM
Phadia US, Inc.
Immunology · 102d
Cleared Dec 29, 2006
NIO FUSION 4MP
K062905 · LLZ
Barcoview
Radiology · 93d
Cleared Dec 29, 2006
RAINBOW ADHESIVE CO-OXIMETRY SENSORS
K063140 · DQA
Masimo Corporation
Anesthesiology · 74d
Cleared Dec 29, 2006
MODIFICATION TO HEALTH BUDDY APPLIANCE
K063612 · DRG
Health Hero Network, Inc.
Cardiovascular · 25d
Cleared Dec 28, 2006
DBX DEMINERALIZED BONE MATRIX PUTTY/PASTE/MIX
K053218 · MQV
Musculoskeletal Transplant Foundation
Orthopedic · 406d