FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
71881–71904 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 2003
CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM
K023096 · HSD
Std Mfg., Inc.
Orthopedic · 204d
Cleared Apr 10, 2003
BIOFLEX PROFESSIONAL THERAPY SYSTEM
K023621 · ILY
Meditech International, Inc.
Physical Medicine · 163d
Cleared Apr 10, 2003
VITALCARE URETHRAL CATHETER RED RUBBER
K023872 · EZD
Vitalcare, Inc.
Gastroenterology & Urology · 141d
Cleared Apr 10, 2003
EVERSTICK PERIO
K030072 · EBI
Stick Tech , Ltd.
Dental · 92d
Cleared Apr 10, 2003
CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM
K030151 · LZO
Hayes Medical, Inc.
Orthopedic · 85d
Cleared Apr 10, 2003
RELAXOR PERFECT TOUCH AIR MASSAGING SYSTEM
K030437 · IRP
Salton, Inc.
Physical Medicine · 59d
Cleared Apr 10, 2003
I-125 RAPID STRAND, MODEL 7000
K030594 · KXK
Amersham Health
Radiology · 44d
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