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
74425–74448 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 2002
GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE (PROTEIN CONTENT...
K022343 · LYY
Pt. Wrp Buana Multicorpora
General Hospital · 59d
Cleared Sep 16, 2002
POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES
K022600 · LYZ
Shijiazhuang Wally Plastics Co., Ltd.
General Hospital · 42d
Cleared Sep 16, 2002
SYNTHETIC POWDER FREE VINYL PATIENT EXAM GLOVES
K022639 · LYZ
Shijiazhuang Holy Plastics Co., Ltd.
General Hospital · 39d
Cleared Sep 16, 2002
POWDERED SYNTHETIC VINYL EXAM GLOVES
K022702 · LYZ
Shijiazhuang Holy Plastics Co., Ltd.
General Hospital · 33d
Cleared Sep 16, 2002
MODIFICATION TO PLAYTEX TAMPONS #24002
K022882 · HIL
Playtex Products, Inc.
Obstetrics & Gynecology · 17d
Cleared Sep 13, 2002
DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11
K014141 · DXN
Digibio Technology Corp.
Cardiovascular · 270d
Cleared Sep 13, 2002
AB BELT
K020427 · NGX
The Dezac Group
Physical Medicine · 217d
Cleared Sep 13, 2002
AB BELT PRO
K020429 · NGX
The Dezac Group
Physical Medicine · 217d
Cleared Sep 13, 2002
RSV OIA
K021172 · GOG
Thermo Biostar, Inc.
Microbiology · 154d
Cleared Sep 13, 2002
RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND
K021483 · IMI
Rich-Mar Corp.
Physical Medicine · 128d
Cleared Sep 13, 2002
BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN...
K021687 · GQG
Binax, Inc.
Microbiology · 114d
Cleared Sep 13, 2002
LASERSYSTEM BEAUTYSTAR 532
K021975 · GEX
Asclepion-Meditec AG
General & Plastic Surgery · 88d
Cleared Sep 13, 2002
SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3
K021989 · LFL
Integra Neurosciences
General & Plastic Surgery · 87d
Cleared Sep 13, 2002
TITAN MICRO CATHETER, MODEL 105-5074-153
K022003 · DYB
Micro Therapeutics, Inc.
Cardiovascular · 86d
Cleared Sep 13, 2002
CONDUCTIVE GEL
K022006 · GYB
The Dezac Group
Neurology · 86d
Cleared Sep 13, 2002
URETERAL ACCESS SHEATH SET (UASS)
K022135 · KOD
Boston Scientific Corp
Gastroenterology & Urology · 74d
Cleared Sep 13, 2002
NORMED DISTAL RADIUS RECONSTRUCTION SYSTEM
K022231 · HRS
Osteomedics, Inc.
Orthopedic · 65d
Cleared Sep 13, 2002
COATED VICRYL* (POLYGLACTIN 910) SUTURE
K022269 · GAM
Ethicon, Inc.
General & Plastic Surgery · 60d
Cleared Sep 13, 2002
TOTAL BILIRUBIN
K022339 · CIG
Abbott Laboratories
Chemistry · 57d
Cleared Sep 13, 2002
PRESS-MATE PM-2100 VITAL SIGN MONITOR
K022537 · MWI
Colin Medical Instruments Corp.
Cardiovascular · 43d
Cleared Sep 13, 2002
COMFY HIGH RISER WHEELCHAIR
K022617 · IOR
Lenjoy Medical Engineering, Inc.
Physical Medicine · 37d
Cleared Sep 13, 2002
TRANSFER COMPANION HR 3000 MANUAL WHEELCHAIR
K022699 · IOR
Forever Young Ent. Co., Ltd.
Physical Medicine · 31d
Cleared Sep 13, 2002
DELUXE MANUAL WHEELCHAIR HW 4000
K022700 · IOR
Forever Young Ent. Co., Ltd.
Physical Medicine · 31d
Cleared Sep 13, 2002
PTA AND PTV
K022722 · DQY
NuMED, Inc.
Cardiovascular · 28d