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
102001–102024 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 11, 1995
RIGHT-ON ADHESIVE BOUDING SYSTEM
K952643 · DYH
Tp Orthodontics, Inc.
Dental · 32d
Cleared Jul 11, 1995
BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK
K952689 · BSJ
Owens-Brigam Medical Co.
Anesthesiology · 29d
Cleared Jul 11, 1995
DEVMED REUSEABLE TROCAR SYSTEM
K952723 · GCJ
Devmed Group, Inc.
General & Plastic Surgery · 26d
Cleared Jul 11, 1995
ETHICON ARTHROSCOPIC KNOT PUSHER
K952814 · GCJ
Ethicon, Inc.
General & Plastic Surgery · 22d
Cleared Jul 10, 1995
CAPCARD
K942930 · FMI
Capcard, Inc.
General Hospital · 383d
Cleared Jul 10, 1995
BUFFALO FILTER REPLACEMENT FILTER #BSPF030
K943226 · FYD
Buffalo Filter Co., Inc.
General Hospital · 369d
Cleared Jul 10, 1995
SHARPS AWAY
K943765 · FMI
Biomedical Waste Systems, Inc.
General Hospital · 342d
Cleared Jul 10, 1995
URESIL(R) GUIDEWIRE
K945934 · DQX
Uresil Corp.
Cardiovascular · 217d
Cleared Jul 10, 1995
AUTO SYRINGE(R) AS50 INFUSION PUMP
K945942 · FRN
Baxter Healthcare Corp
General Hospital · 217d
Cleared Jul 10, 1995
DEVONS POINT LOK NEEDLE PROTECTION DEVICE
K946289 · FMI
Devon Industries, Inc.
General Hospital · 195d
Cleared Jul 10, 1995
DEPUY SET SCREW
K950833 · HWC
Depuy, Inc.
Orthopedic · 136d
Cleared Jul 10, 1995
COLD LIGHT SOURCE LOS 150
K951829 · EQH
Laser Optik Systeme GmbH & Co. KG
Ear, Nose, Throat · 81d
Cleared Jul 10, 1995
WELCH ALLY OTOSCOPE
K952578 · ERA
Welch Allyn, Inc.
Ear, Nose, Throat · 35d
Cleared Jul 10, 1995
STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT
K952678 · KDG
Avail-Southwest Division
General & Plastic Surgery · 28d
Cleared Jul 07, 1995
OCR II & OCM II
K942989 · FLE
Chambermaid Products Co.
General Hospital · 382d
Cleared Jul 07, 1995
BUFFALO FILTER REPLACEMENT FILTER #BSUCF03
K943227 · FYD
Buffalo Filter Co., Inc.
General Hospital · 366d
Cleared Jul 07, 1995
RASCAL-II RESPIRATORY AND ANESTHETIC GAS MONITOR
K944052 · CCK
Ohmeda Medical
Anesthesiology · 322d
Cleared Jul 07, 1995
ECG ELECTRODE
K944260 · DRX
Msb , Ltd.
Cardiovascular · 311d
Cleared Jul 07, 1995
PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES)
K944451 · JOH
Passy-Muir, Inc.
Anesthesiology · 298d
Cleared Jul 07, 1995
INTEGRATED MOVEMENT ANALYZER
K944787 · IKN
Maryrose
Neurology · 282d
Cleared Jul 07, 1995
MEDI-TRACE(R) 500 ECG ELECTRODE
K945479 · DRX
Graphic Controls Corp.
Cardiovascular · 241d
Cleared Jul 07, 1995
POLYGRAM SOFTWARE
K946322 · BZG
Synectics Medical, Inc.
Anesthesiology · 191d
Cleared Jul 07, 1995
GRAPHIC CONTROLS PROTRACE ECG ELECTRODE
K950485 · DRX
Graphic Controls Corp.
Cardiovascular · 151d
Cleared Jul 07, 1995
MODIFIED COHERENT ULTRAPULSE CO2 SURGICAL LASERS
K951812 · GEX
Lumenis, Inc.
General & Plastic Surgery · 79d