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
75529–75552 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 09, 2002
URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC...
K012758 · FGB
Circon Video
Gastroenterology & Urology · 235d
Cleared Apr 09, 2002
FRIALOC DENTAL IMPLANT SYSTEM
K013067 · DZE
Friadent GmbH
Dental · 209d
Cleared Apr 09, 2002
ASTRONOMER PLUS SYSTEM
K013349 · DQK
Ep Technologies, Inc.
Cardiovascular · 182d
Cleared Apr 09, 2002
HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READER
K014025 · DQA
Hommed, LLC
Anesthesiology · 124d
Cleared Apr 09, 2002
ATHOS LASER
K020072 · GEX
Quantel Medical
General & Plastic Surgery · 90d
Cleared Apr 09, 2002
FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN
K020139 · LPL
Ciba Vision Corporation
Ophthalmic · 83d
Cleared Apr 09, 2002
AHL GENERIC GLASS IONOMER AESTHETIC RESTORATIVE
K020376 · EMA
Advanced Healthcare , Ltd.
Dental · 64d
Cleared Apr 09, 2002
STRATASIS SLING KIT
K020654 · PAG
Cook Biotech, Inc.
Gastroenterology & Urology · 40d
Cleared Apr 09, 2002
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS
K020832 · GEI
Arthrocare Corp.
General & Plastic Surgery · 26d
Cleared Apr 09, 2002
MODEL GT010706 ELECTRONIC THERMOMETER
K021052 · FLL
Global Treasure Industries , Ltd.
General Hospital · 8d
Cleared Apr 08, 2002
MONITORING SYSTEM,MODEL ARGUS PB-1000
K012226 · MHX
Schiller AG
Cardiovascular · 266d
Cleared Apr 08, 2002
HYGIA HEALTH SERVICE REPROCESSED KENDALL SCD SLEEVE, MODELS # 5329, 5330,...
K012417 · JOW
Hygia Health Services, Inc.
Cardiovascular · 252d
Cleared Apr 08, 2002
AL-2000 COMBINED BIOMETER AND PACHYMETER
K012803 · IYO
Tomey Corp.
Radiology · 230d
Cleared Apr 08, 2002
BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM
K013672 · JEY
Azary Technologies, LLC
Dental · 153d
Cleared Apr 08, 2002
U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000
K013848 · IYN
U-Systems, Inc.
Radiology · 139d
Cleared Apr 08, 2002
HDR MIAMI APPLICATOR
K020176 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 80d
Cleared Apr 08, 2002
SURGIC IV IMPLANT CONTROL UNIT
K020327 · EBW
Nakanishi, Inc.
Dental · 67d
Cleared Apr 08, 2002
CHEMISTRY CALIBRATOR
K020454 · JIT
Jas Diagnostics, Inc.
Chemistry · 56d
Cleared Apr 08, 2002
MODEL GT980201 ELECTRONIC THERMOMETER
K021028 · FLL
Global Treasure , Ltd.
General Hospital · 10d
Cleared Apr 05, 2002
HISONIC-TRD TINNITUS RELIEF DEVICE
K013253 · KLW
Hearing Innovations, Inc.
Ear, Nose, Throat · 189d
Cleared Apr 05, 2002
RUBICOR BREAST BIOPSY DEVICE
K020047 · GEI
Rubicor Medical, Inc.
General & Plastic Surgery · 88d
Cleared Apr 05, 2002
VIRIDIS DERMA LASER
K020071 · GEX
Quantel Medical
General & Plastic Surgery · 86d
Cleared Apr 05, 2002
NETLINK/NETSCAN
K020213 · DXH
Rozinn Electronics, Inc.
Cardiovascular · 73d
Cleared Apr 05, 2002
SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2
K020252 · FMF
Harvest Technologies, Corp.
General Hospital · 71d