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
71113–71136 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 27, 2003
ELCACAM
K032070 · EIA
A-Dec, Inc.
Dental · 55d
Cleared Aug 27, 2003
CLICK HOLTER
K032276 · MWJ
Remco Italia S.P.A.
Cardiovascular · 35d
Cleared Aug 27, 2003
MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM...
K032360 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 27d
Cleared Aug 27, 2003
DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM)
K032498 · NHA
Straumann USA
Dental · 14d
Cleared Aug 26, 2003
TSO3 OZONE STERILIZER, MODEL 125L
K020875 · FLF
Technologies of Sterilization With...
General Hospital · 526d
Cleared Aug 26, 2003
UROPOWER
K022721 · EXY
W.O.M. World of Medicine AG
Gastroenterology & Urology · 375d
Cleared Aug 26, 2003
OASYS-ORAL AIRWAY SYSTEM
K030440 · LRK
Mark Abramson, D.D.S., Inc.
Dental · 196d
Cleared Aug 26, 2003
HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K031678 · DQX
Guidant Corp.
Cardiovascular · 88d
Cleared Aug 26, 2003
VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES
K031740 · DQA
Welch Allyn Protocol, Inc.
Anesthesiology · 83d
Cleared Aug 26, 2003
DISPOSABLE POWERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
K032236 · LYZ
Est International Corporation
General Hospital · 36d
Cleared Aug 26, 2003
GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200
K032250 · KRH
Edwards Lifesciences, LLC
Cardiovascular · 35d
Cleared Aug 26, 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR
K032272 · LYZ
Est International Corporation
General Hospital · 34d
Cleared Aug 26, 2003
DISPOSABLE N-PE MICKROKERATOME BLADES
K032297 · HNO
Oasis Medical, Inc.
Ophthalmic · 32d
Cleared Aug 26, 2003
MODIFICATION TO OUTBACK CATHETER
K032298 · DQY
Lumend, Inc.
Cardiovascular · 32d
Cleared Aug 26, 2003
ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPHIC CATHETER
K032376 · DQO
AngioDynamics, Inc.
Cardiovascular · 25d
Cleared Aug 25, 2003
VISUALINE METHADONE DIPSTRIPTEST
K023856 · DJR
Sun Biomedical Laboratories, Inc.
Chemistry · 279d
Cleared Aug 25, 2003
NEUROTECH BAXOLVE TYPE 294
K023913 · GZJ
Bio-Medical Research, Ltd.
Neurology · 273d
Cleared Aug 25, 2003
MATCH PRESS PRESSABLE CERAMIC
K024250 · EIH
Davis Schottlander & Davis, Ltd.
Dental · 245d
Cleared Aug 25, 2003
SONIK LDI 20 AIR
K030374 · CAF
Evit Labs, Inc.
Anesthesiology · 202d
Cleared Aug 25, 2003
DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE
K030977 · DYH
Dentaurum
Dental · 150d
Cleared Aug 25, 2003
DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE
K030980 · DYH
Dentaurum
Dental · 150d
Cleared Aug 25, 2003
LYRA NASAL MASK
K031883 · BZD
Sensor Medics Corp.
Anesthesiology · 68d
Cleared Aug 25, 2003
LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER...
K031921 · JJY
Cliniqa Corporation
Chemistry · 63d
Cleared Aug 25, 2003
EASY PULSE II OXYGEN CONSERVER
K032018 · NFB
Precision Medical, Inc.
Anesthesiology · 56d