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
81985–82008 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 18, 2000
SURGILIGHT, INC EXCIMER LASER
K993328 · GEX
Surgilight, Inc.
General & Plastic Surgery · 288d
Cleared Jul 18, 2000
BIOPACK
K993685 · ILY
Bioscan, Inc.
Physical Medicine · 260d
Cleared Jul 18, 2000
LIGHT PATCH
K993686 · ILY
Bioscan, Inc.
Physical Medicine · 260d
Cleared Jul 17, 2000
RIZA BAND STRETCHER (RBS)-60000
K001236 · FHN
R-Med, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 17, 2000
GE MARQUETTE PRISM INFORMATION SERVER APPLICATIONS
K001268 · MHX
General Electric Medical Systems...
Cardiovascular · 88d
Cleared Jul 17, 2000
MEDICAL IMAGE MERGE (MIM)
K001276 · KPS
Syntermed, Inc.
Radiology · 87d
Cleared Jul 17, 2000
SPINAL CORD AND IMMOBILIZATION TRACTION SYSTEM
K001296 · ITH
Cavendish Scott, Inc.
Physical Medicine · 84d
Cleared Jul 17, 2000
INTRODUCER SHEATH
K001328 · FEC
Novasys Medical, Inc.
Gastroenterology & Urology · 82d
Cleared Jul 17, 2000
KARL STORZ 3D VIDEO SYSTEM
K001362 · GCI
Karl Storz Imaging, Inc.
General & Plastic Surgery · 80d
Cleared Jul 17, 2000
ACCUSONIC PLUS, MODEL AP-100
K001370 · IMI
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 77d
Cleared Jul 17, 2000
ACCUSET SENSOR, MODEL 2000
K001386 · FEN
Pelvicare, Inc.
Gastroenterology & Urology · 76d
Cleared Jul 17, 2000
LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE
K001582 · MOS
Usa Instruments, Inc.
Radiology · 56d
Cleared Jul 17, 2000
MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159
K001698 · FFS
Cogent Light Technologies, Inc.
Gastroenterology & Urology · 45d
Cleared Jul 17, 2000
GC FUJICEM
K001730 · EMA
GC America, Inc.
Dental · 40d
Cleared Jul 17, 2000
ARTHROCARE FLOW CONTROL UNIT
K001904 · GEI
Arthrocare Corp.
General & Plastic Surgery · 25d
Cleared Jul 17, 2000
UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE
K993996 · MEG
Univec, Inc.
General Hospital · 236d
Cleared Jul 17, 2000
PHARMASEED, MODEL BT-125-3
K994018 · KXK
Syncor Pharmaceuticals, Inc.
Radiology · 234d
Cleared Jul 14, 2000
SAMARCO SPIDER PLATES
K001271 · KTW
Biomet, Inc.
Orthopedic · 85d
Cleared Jul 14, 2000
COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT...
K001924 · KGO
Allegiance Healthcare Corp.
General Hospital · 21d
Cleared Jul 14, 2000
PHARMASEED, MODEL BT-103-3
K994016 · KXK
Syncor Pharmaceuticals, Inc.
Radiology · 231d
Cleared Jul 13, 2000
DATEX-OHMEDA NETWORK AND CENTRAL
K000647 · MSX
Datex-Ohmeda, Inc.
Cardiovascular · 136d
Cleared Jul 13, 2000
ISOLETTE INFANT INCUBATOR, MODEL C2HS
K001242 · FMZ
Hill-Rom Air-Shields
General Hospital · 86d
Cleared Jul 13, 2000
WELCH ALLYN INSTRUMENT INTERFACE MODULE
K001265 · MWI
Welch Allyn, Inc.
Cardiovascular · 85d
Cleared Jul 13, 2000
RETCAM II
K001275 · HKI
Massie Research Laboratories, Inc.
Ophthalmic · 84d