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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
35425–35448 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 20, 2015
STERILUCENT STERILIZATION CONTAINER SYSTEM
K142109 · KCT
Sterilucent, Inc.
General Hospital · 169d
Cleared Jan 20, 2015
ENDOCHOICE WATER BOTTLE CAP SYSTEM
K142155 · FEQ
Endochoice, Inc.
Gastroenterology & Urology · 167d
Cleared Jan 20, 2015
Zmachine
K142825 · OLZ
Consolidated Research of Richmond, Inc.
Neurology · 112d
Cleared Jan 20, 2015
Synapse Occipital-Cervical-Thoracic (OCT) System
K142838 · NKG
Synthes USA Products, LLC
Orthopedic · 112d
Cleared Jan 20, 2015
SnapShot Fixation System
K143037 · JDR
Biomet Manufacturing Corp
Orthopedic · 90d
Cleared Jan 20, 2015
Speedicath Compact Male
K143182 · GBM
Coloplast A/S
Gastroenterology & Urology · 76d
Cleared Jan 20, 2015
Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes)
K143317 · JOW
Currie Medical Specialties, Inc.
Cardiovascular · 62d
Cleared Jan 20, 2015
LifeGlobal Global HP
K143498 · MQL
Life Global Group, LLC
Obstetrics & Gynecology · 41d
Cleared Jan 20, 2015
MUSE System
K143634 · ODE
Medigus , Ltd.
Gastroenterology & Urology · 29d
Cleared Jan 18, 2015
DECISIO HEALTH PATIENT DASHBOARD
K142106 · MWI
Decisio Health, Inc.
Cardiovascular · 170d
Cleared Jan 18, 2015
TruWave Disposable Pressure Transducer
K142749 · DXO
Edwards Lifesciences, LLC
Cardiovascular · 116d
Cleared Jan 16, 2015
ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET
K131950 · FIE
Summit International Medical...
Gastroenterology & Urology · 568d
Cleared Jan 16, 2015
ZOLL E SERIES
K133239 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 452d
Cleared Jan 16, 2015
REVOLUTION FULLFACE MASK
K140580 · BZD
Respironics Inc. (Dba Philips...
Anesthesiology · 316d
Cleared Jan 16, 2015
EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM
K141206 · GAW
Edwards Lifesciences, LLC
General & Plastic Surgery · 252d
Cleared Jan 16, 2015
VICTUS FEMTOSECOND LASER PLATFORM
K141379 · OOE
Technolas Perfect Vision GmbH
Ophthalmic · 234d
Cleared Jan 16, 2015
VM PACS WITH VM MEDICAL WORKSTATION
K141561 · LLZ
Visual Medica
Radiology · 218d
Cleared Jan 16, 2015
COLLAGEN DURA MEMBRANE
K141608 · GXQ
Collagen Matrix, Inc.
Neurology · 214d
Cleared Jan 16, 2015
PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0...
K141789 · FRN
Hospira, Inc.
General Hospital · 198d
Cleared Jan 16, 2015
HIVOX SPOPAD EMS
K141921 · NGX
Hivox Biotek, Inc.
Physical Medicine · 184d
Cleared Jan 16, 2015
Pulse oximeter NBM-200
K142209 · DQA
Orsense, Ltd.
Anesthesiology · 158d
Cleared Jan 16, 2015
MCS Bone Graft
K142276 · MQV
Biostructures, LLC
Orthopedic · 154d
Cleared Jan 16, 2015
Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White...
K142283 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 154d
Cleared Jan 16, 2015
LaborView LV1000
K142583 · OSP
Obmedical Company
Obstetrics & Gynecology · 123d