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
77713–77736 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 2001
MODIFICATION TO BRAIDED GUIDING INTRODUCER
K013202 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 28d
Cleared Oct 23, 2001
POINT 4 FLOWABLE 2
K013325 · EBF
Kerr Dental Materials Center
Dental · 18d
Cleared Oct 22, 2001
MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER
K011392 · MSS
Micra Instruments
Ophthalmic · 168d
Cleared Oct 22, 2001
CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM
K011502 · DZE
Crystal-Seal Dental Implants
Dental · 159d
Cleared Oct 22, 2001
AMEDITECH IMMUTEST DRUG SCREEN THC
K011813 · LDJ
Ameditech, Inc.
Toxicology · 133d
Cleared Oct 22, 2001
AMEDITECH IMMUTEST DRUG SCREEN COC
K011814 · DIO
Ameditech, Inc.
Toxicology · 133d
Cleared Oct 22, 2001
SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)
K012453 · HBC
Sodemsystems
Neurology · 82d
Cleared Oct 22, 2001
SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)
K012457 · HBC
Sodemsystems
Neurology · 82d
Cleared Oct 22, 2001
METAL SCREW ANCHOR
K012503 · MBI
Biomet Manufacturing, Inc.
Orthopedic · 80d
Cleared Oct 22, 2001
ICE
K012528 · EBF
Southern Dental Industries, Ltd.
Dental · 77d
Cleared Oct 22, 2001
ROK
K012529 · EBF
Southern Dental Industries, Ltd.
Dental · 77d
Cleared Oct 22, 2001
REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS
K012625 · GEI
Alliance Medical Corp.
General & Plastic Surgery · 70d
Cleared Oct 22, 2001
NAVIGUS II MR
K012719 · HAW
Image-Guided Neurologics, Inc.
Neurology · 69d
Cleared Oct 22, 2001
ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS
K012777 · JZO
Bayer Corp.
Immunology · 63d
Cleared Oct 22, 2001
D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM
K012821 · HRN
Dutch Ophthalmic USA, Inc.
Ophthalmic · 60d
Cleared Oct 22, 2001
COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER
K012955 · NEU
Bioform, Inc.
General & Plastic Surgery · 48d
Cleared Oct 22, 2001
STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)
K013059 · GAQ
Stony Brook Surgical Innovations, Inc.
General & Plastic Surgery · 41d
Cleared Oct 22, 2001
BIOSCANNER PLUS
K013173 · CHH
Polymer Technology Systems, Inc.
Chemistry · 28d
Cleared Oct 22, 2001
STATUSBLUE
K013237 · ELW
Dmg USA, Inc.
Dental · 24d
Cleared Oct 22, 2001
ASTRALIS 7, MODEL 557545
K013277 · EBZ
Ivoclar Vivadent, Inc.
Dental · 20d
Cleared Oct 19, 2001
RIWO SYSTEM TRAYS
K012309 · FEB
Richard Wolf Medical Instruments Corp.
General Hospital · 88d
Cleared Oct 19, 2001
POWERPRO BATTERY SYSTEM
K012320 · HAB
Linvatec Corp.
General & Plastic Surgery · 88d
Cleared Oct 19, 2001
AML HIP PROSTHESIS
K012364 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 85d
Cleared Oct 19, 2001
MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM
K012510 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 74d