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
77233–77256 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 2001
ASHA TREATMENT PLANNING SYSTEM, MODEL ASHA TPS
K002132 · MUJ
Intelligent Instruments Pvt. , Ltd.
Radiology · 461d
Cleared Oct 18, 2001
STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES
K003857 · JOW
Sterilmed, Inc.
Cardiovascular · 309d
Cleared Oct 18, 2001
LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS
K012409 · NHB
Walter Lorenz Surgical, Inc.
Ear, Nose, Throat · 80d
Cleared Oct 18, 2001
SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM
K012424 · JAA
Shimadzu Corp.
Radiology · 80d
Cleared Oct 18, 2001
WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL
K012522 · ITX
National Therapy Products, Inc.
Radiology · 73d
Cleared Oct 18, 2001
PROSAFE SAFETY SYRINGE
K012726 · MEG
Hou-Se Medical, Inc.
General Hospital · 64d
Cleared Oct 18, 2001
SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM
K012961 · JDI
Sulzer Orthopedics, Inc.
Orthopedic · 44d
Cleared Oct 18, 2001
N LP(A) CONTROL SY
K013130 · JJX
Dade Behring, Inc.
Chemistry · 29d
Cleared Oct 18, 2001
MR-GUIDE 2000
K013150 · LNH
Ultraguide , Ltd.
Radiology · 28d
Cleared Oct 18, 2001
MOSFET AUTOSENSE, MODEL TN-RD-60
K013279 · IYE
Thomson & Nielsen Electronics, Ltd.
Radiology · 16d
Cleared Oct 17, 2001
SEED SELECTRON MODEL V. 1.0
K010032 · JAQ
Nucletron Corp.
Radiology · 287d
Cleared Oct 17, 2001
HOLY DRAGON STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE
K011247 · MQX
Acusupply, Inc.
General Hospital · 177d
Cleared Oct 17, 2001
METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088
K012265 · FCW
Circon Video
Gastroenterology & Urology · 90d
Cleared Oct 17, 2001
THEKEN SMALL CEMENT RESTRICTOR
K012278 · JDK
Theken Surgical,Llc
Orthopedic · 90d
Cleared Oct 17, 2001
FLEXI-SITE SP02 EAR SENSOR
K012333 · DPZ
Epic Medical Equipment Services, Inc.
Anesthesiology · 85d
Cleared Oct 17, 2001
VANGUARD REPROCESSED COMPRESSION GARMENT
K012403 · JOW
Vanguard Medical Concepts, Inc.
Cardiovascular · 79d
Cleared Oct 17, 2001
SONICATOR PLUS 930, MODEL ME 930
K013192 · IMI
Mettler Electronics Corp.
Physical Medicine · 22d
Cleared Oct 17, 2001
LUXABITE
K013236 · ELW
Dmg USA, Inc.
Dental · 19d
Cleared Oct 16, 2001
ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)
K011337 · JOZ
Accumetrics, Inc.
Hematology · 167d
Cleared Oct 16, 2001
VERTRAN STANDING WHEELCHAIR
K011530 · IPL
Fena Design, Inc.
Physical Medicine · 152d
Cleared Oct 16, 2001
VBR
K012254 · MQP
Osteotech, Inc.
Orthopedic · 90d
Cleared Oct 16, 2001
ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW
K012339 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 84d
Cleared Oct 16, 2001
VANGUARD REPROCESSED ARTHROSCOPIC BLADES
K012346 · HRX
Vanguard Medical Concepts, Inc.
Orthopedic · 84d
Cleared Oct 16, 2001
STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION
K012482 · LNS
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 75d