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
75121–75144 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 2002
QUICKVUE ONE-STEP HCG-URINE
K020799 · JHI
Quidel Corp.
Chemistry · 66d
Cleared May 17, 2002
QUICKVUE ONE-STEP HCG-COMBO
K020801 · JHI
Quidel Corp.
Chemistry · 66d
Cleared May 17, 2002
MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE
K020939 · LTT
Dade Microscan, Inc.
Microbiology · 56d
Cleared May 17, 2002
HOLY DRAGON BRAND ACUPUNCTURE NEEDLES
K021095 · MQX
Wujiang City Hua Xin Medical...
General Hospital · 43d
Cleared May 17, 2002
24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED...
K021212 · MSD
Spire Biomedical, Inc.
Gastroenterology & Urology · 30d
Cleared May 17, 2002
SMARTWIRE/SMARTMAP PRESSURE SYSTEM
K021219 · DQX
Jomed, Inc.
Cardiovascular · 30d
Cleared May 17, 2002
Z3 GUIDE CATHETER
K021256 · DQY
Medtronic Vascular
Cardiovascular · 28d
Cleared May 17, 2002
PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719
K021274 · MEB
Baxter Healthcare Corp
General Hospital · 25d
Cleared May 17, 2002
SIMPLICITY EASY ACCESS P INFUSION SET
K021487 · FPA
Sterling Medivations, Inc.
General Hospital · 9d
Cleared May 16, 2002
MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER
K011726 · MQV
Millenium Biologix, Inc.
Orthopedic · 346d
Cleared May 16, 2002
MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP)
K013596 · JOZ
Accumetrics, Inc.
Hematology · 197d
Cleared May 16, 2002
IMMIX BONE GRAFT EXTENDER
K013764 · KKY
Osteogenics Biomedical, Inc.
General & Plastic Surgery · 184d
Cleared May 16, 2002
APATIGHT-TCP BONE GRAFT SUBSTITUTE
K013966 · MQV
Cerabio, LLC
Orthopedic · 164d
Cleared May 16, 2002
OSSEOTITE NT DENTAL IMPLANTS & ACCESSORIES
K014235 · DZE
Implant Innovations, Inc.
Dental · 141d
Cleared May 16, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN...
K020398 · LON
Dade Behring, Inc.
Microbiology · 99d
Cleared May 16, 2002
MTI ST#1 SILICONE PESSARY
K020512 · HHW
Medical Technology and Innovations, Inc.
Obstetrics & Gynecology · 90d
Cleared May 16, 2002
EPY-50
K020513 · GEX
Ddc Technologies, Inc.
General & Plastic Surgery · 90d
Cleared May 16, 2002
PULPDENT GLAZE II
K020514 · KLE
Pulpdent Corporation
Dental · 90d
Cleared May 16, 2002
CARE IFC PLUS
K020516 · LIH
Care Rehab, Inc.
Neurology · 90d
Cleared May 16, 2002
APEX INTRAMEDULLARY NAIL SYSTEM
K020562 · HSB
Magly Orthopedics, LLC
Orthopedic · 85d
Cleared May 16, 2002
BCLEAR
K020591 · FTC
Lumenis
General & Plastic Surgery · 83d
Cleared May 16, 2002
HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY...
K020608 · LPL
Poly Vue Technolgies, Inc.
Ophthalmic · 80d
Cleared May 16, 2002
SURGE-FREE ASPIRATION ADAPTER
K020734 · HQC
Staar Surgical Co.
Ophthalmic · 71d
Cleared May 16, 2002
XTRAC EXCIMER LASER SYSTEM, MODEL AL7000
K020847 · GEX
Photo Medex, Inc.
General & Plastic Surgery · 62d