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
76249–76272 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 16, 2002
EBI AIS SPINE SYSTEM
K020887 · MQP
Ebi, L.P.
Orthopedic · 59d
Cleared May 16, 2002
BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS
K020927 · LPL
Bausch & Lomb
Ophthalmic · 56d
Cleared May 16, 2002
VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA
K020956 · MUI
Microtek Medical, Inc.
Radiology · 52d
Cleared May 16, 2002
SHANGHAI GLOVMAX ENTERPRISE POWDERFREE BLUE NITRILE EXAMINATION GLOVES
K021001 · LZA
Shanghai Glovmax Enterprise Co.,Ltd
General Hospital · 49d
Cleared May 16, 2002
HEMOSIL HIGH ABNORMAL CONTROL ASSAYED
K021024 · GGN
Instrumentation Laboratory CO
Hematology · 48d
Cleared May 16, 2002
EBI XFIX RAIL SYSTEM
K021031 · KTT
Ebi, L.P.
Orthopedic · 48d
Cleared May 16, 2002
PHILIPS TL 20W/01RS UV-B, PHILIPS PL-S 9W/01/2P UV, AND PHILIPS PL-L...
K021092 · FTC
Philips Lighting Co.
General & Plastic Surgery · 42d