FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
71401–71424 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML
K031429 · LON
Bd Diagnostic Systems
Microbiology · 31d
Cleared Jun 06, 2003
AMBULATORY BLOOD PRESSURE (ABP) 92506 REPORT MANAGEMENT SYSTEM (RMS), MODEL...
K031479 · DXN
Datex-Ohmeda, Inc.
Cardiovascular · 29d
Cleared Jun 06, 2003
CUFFLOK ANCHOR
K031519 · MAI
Mitek Worldwide
Orthopedic · 22d
Cleared Jun 06, 2003
SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE
K031573 · KTT
Synthes (Usa)
Orthopedic · 17d
Cleared Jun 06, 2003
BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAFETY SYRINGE TRAY
K031594 · MEG
M.K. Meditech Co. , Ltd.
General Hospital · 16d
Cleared Jun 06, 2003
MEDELA PUMP IN STYLE ADVANCED BREAST PUMP
K031614 · HGX
Medela, Inc.
Obstetrics & Gynecology · 14d
Cleared Jun 06, 2003
CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI
K031629 · HKI
Canon USA, Inc.
Ophthalmic · 10d
Cleared Jun 06, 2003
PRESSURE WIRE SENSOR, MODELS 12004/12304
K031662 · DXO
Radi Medical Systems AB
Cardiovascular · 9d
Cleared Jun 05, 2003
MERDOC SYSTEM
K022393 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 317d
Cleared Jun 05, 2003
EZMANAGER PLUS
K022394 · LZG
Animas Corp.
General Hospital · 317d
Cleared Jun 05, 2003
PRE-POWDERED LATEX ORTHOPEDIC SURGEON'S GLOVES
K030444 · KGO
Primus Gloves Private , Ltd.
General Hospital · 114d
Cleared Jun 05, 2003
POWDER FREE LATEX MICROSURGERY GLOVES WITH BROWN COLOR AND PROTEIN LABELING...
K030445 · KGO
Primus Gloves Private , Ltd.
General Hospital · 114d
Cleared Jun 05, 2003
C-PORT
K030636 · LJT
Clinisurg Vascular Products, LLC
General Hospital · 97d
Cleared Jun 05, 2003
SCB COMPUTER MOTION INTERFACE CONTROLLER
K030718 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 90d
Cleared Jun 05, 2003
POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENT
K030727 · EMA
Healex Products, Inc.
Dental · 90d
Cleared Jun 05, 2003
PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US
K031470 · BZD
Tyco Healthcare Nancy
Anesthesiology · 27d
Cleared Jun 05, 2003
MODIFICATION TO CAVERMAP SURGICAL AID
K031527 · FGM
Blue Torch Medical Technologies
Gastroenterology & Urology · 21d
Cleared Jun 04, 2003
BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC
K023691 · NFA
Boston Scientific Epi
Cardiovascular · 215d
Cleared Jun 04, 2003
SHELHIGH BIORING
K023940 · KRH
Shelhigh, Inc.
Cardiovascular · 190d
Cleared Jun 04, 2003
PALOMAR LIGHTCUBE
K024179 · ILY
Palomar Medical Products, Inc.
Physical Medicine · 168d
Cleared Jun 04, 2003
CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT
K030700 · GEX
Biolitec, Inc.
General & Plastic Surgery · 90d
Cleared Jun 04, 2003
BIO-MODULAR SHOULDER SYSTEM
K030710 · KWT
Biomet, Inc.
Orthopedic · 90d
Cleared Jun 04, 2003
LAP DISC 120 X 120MM X2CM, MODEL LD111, LAP DISC 120 X 120MMX 7CM,MODEL LD112
K030824 · GCJ
Hakko Medical Co., Ltd.
General & Plastic Surgery · 82d
Cleared Jun 04, 2003
3-CCD DIGITAL CAMERA SYSTEM
K031098 · GCJ
Linvatec Corp.
General & Plastic Surgery · 58d