FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
75649–75672 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 16, 2002
ACCOMMODATOR WHEELCHAIR, MODEL #2000X
K021145 · IOR
Marken International, Inc.
Physical Medicine · 37d
Cleared May 16, 2002
QACA IGG/IGM ELISA KIT HRP
K021192 · MID
Cheshire Diagnostics , Ltd.
Immunology · 31d
Cleared May 16, 2002
CONSTELLATION CATHETERS, MODEL 8031M
K021232 · MTD
Boston Scientific Corp
Cardiovascular · 28d
Cleared May 16, 2002
PORTALLOY 54
K021242 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 27d
Cleared May 16, 2002
STERNGOLD 66, MODEL #1180230
K021367 · EJS
Sterngold
Dental · 16d
Cleared May 16, 2002
SUNSPEX TECHNOLOGIES MODEL SE 02
K021371 · INI
Sunpex Technology Co., Ltd.
Physical Medicine · 16d
Cleared May 16, 2002
SYNTHES (USA) AUTOMATED TACK DRIVER
K021382 · JEY
Synthes (Usa)
Dental · 14d
Cleared May 16, 2002
DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GLOVES,...
K021396 · LZA
Wrp Specialty Products Sdn. Bhd.
General Hospital · 14d