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
73009–73032 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 2003
BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR
K030804 · JIX
Bayer Healthcare, LLC
Chemistry · 28d
Cleared Apr 10, 2003
DEPUY ACROMED VBR SYSTEM
K030833 · MQP
Depuyacromed
Orthopedic · 24d
Cleared Apr 10, 2003
AVANTA CARPAL FUSION PLATING SYSTEM
K030881 · HRS
Avanta Orthopaedics, Inc.
Orthopedic · 21d
Cleared Apr 10, 2003
AAP ACROPLATE
K030909 · HRS
Aap Implantate AG
Orthopedic · 17d
Cleared Apr 10, 2003
GE 3.0T GENERAL PURPOSE FLEX COIL
K030953 · MOS
Ge Medical Systems, Inc.
Radiology · 14d
Cleared Apr 09, 2003
MID STREAM PREGNANCY TEST
K023037 · LCX
Advanced Diagnostics, Inc.
Chemistry · 209d
Cleared Apr 09, 2003
LOOP MICROWAVE ABLATION PROBE
K023311 · GEI
Vivant Medical, Inc.
General & Plastic Surgery · 188d
Cleared Apr 09, 2003
THERMO BUDDY, MODELS TB-100, TB-110, TB-120
K023412 · FLL
Hubdic Co., Ltd.
General Hospital · 180d
Cleared Apr 09, 2003
GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL
K030414 · ELW
Sultan Chemists, Inc.
Dental · 61d
Cleared Apr 09, 2003
MIRAGE ACTIVA MASK
K030798 · BZD
Resmed, Ltd.
Anesthesiology · 27d
Cleared Apr 09, 2003
BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL
K030801 · JJY
Bayer Healthcare, LLC
Chemistry · 27d
Cleared Apr 09, 2003
ALGO 3I NEWBORN HEARING SCREENER
K030823 · GWJ
Natus Medical, Inc.
Neurology · 26d
Cleared Apr 09, 2003
WBR, MODEL HR
K030870 · KPS
U.C.G. Technologies , Ltd.
Radiology · 21d
Cleared Apr 09, 2003
MEDAMICUS FLOWGUARD PEELABLE INTRODUCER
K030905 · DYB
Medamicus, Inc.
Cardiovascular · 16d
Cleared Apr 09, 2003
NOMAD ND1000M AUGMENTED VISION SYSTEM
K030940 · GCJ
Microvision Incorporated
General & Plastic Surgery · 15d
Cleared Apr 09, 2003
EPTFE VASCULAR PROSTHESIS
K030999 · DSY
Vascutek, Ltd.
Cardiovascular · 9d
Cleared Apr 08, 2003
STEREOTAXIS CATHETER ADVANCER SYSTEM
K021802 · DQY
Stereotaxis, Inc.
Cardiovascular · 309d
Cleared Apr 08, 2003
MAS WITH OR WITHOUT SYRINGE
K021876 · HHK
Marina Medical Instruments, Inc.
Obstetrics & Gynecology · 305d
Cleared Apr 08, 2003
PETIT SOPHIA
K021978 · LHD
Nishitomo Co., Inc.
Obstetrics & Gynecology · 295d
Cleared Apr 08, 2003
INVIGRA
K022614 · HIS
Indus Medicare , Ltd.
Obstetrics & Gynecology · 245d
Cleared Apr 08, 2003
TETRIS SPINAL IMPLANT
K022793 · MQP
Signus Medical, LLC
Orthopedic · 228d
Cleared Apr 08, 2003
HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-326L
K023001 · IPF
Home Care Technology Co., Ltd.
Physical Medicine · 211d
Cleared Apr 08, 2003
SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM
K030069 · JEY
Synthes (Usa)
Dental · 90d
Cleared Apr 08, 2003
EMPI ACTION PATCH IONTOPHORESIS SYSTEM
K030395 · EGJ
Empi
Physical Medicine · 62d