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
71905–71928 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 2003
MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000
K030332 · NYN
Bionicare Medical Technologies, Inc.
Neurology · 126d
Cleared Jun 06, 2003
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM
K030738 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 88d
Cleared Jun 06, 2003
MSD CABLE REDUCTION SYSTEM
K030816 · KWP
Medtronic Sofamor Danek
Orthopedic · 84d
Cleared Jun 06, 2003
ENI-EYE Q TORIC (ACOFILCON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR...
K030842 · LPL
Soflex Contact Lens Industries , Ltd.
Ophthalmic · 81d
Cleared Jun 06, 2003
TESCERAFLO A2, MODEL T-21012P
K030951 · EBF
Bisco, Inc.
Dental · 72d
Cleared Jun 06, 2003
CALIBRATION PLASMA LMW HEPARIN
K030964 · JIS
Instrumentation Laboratory CO
Hematology · 71d
Cleared Jun 06, 2003
CONTROL PLASMA LMW HEPARIN
K030965 · GGN
Instrumentation Laboratory CO
Hematology · 71d
Cleared Jun 06, 2003
SYVA EMIT II PLUS AMPHETAMINES ASSAY
K031004 · DKZ
Dade Behring, Inc.
Toxicology · 67d
Cleared Jun 06, 2003
PLUS ORTHOPEDICS CEMENTED HIP STEM
K031165 · JDI
Plus Orthopedics
Orthopedic · 53d
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