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
73681–73704 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 09, 2002
W-5
K022811 · EJT
Ivoclar Vivadent, Inc.
Dental · 47d
Cleared Oct 09, 2002
CLEAR-IT ANTI-FOG, MODEL PS003
K022826 · OCT
Preservation Solutions, Inc.
Gastroenterology & Urology · 44d
Cleared Oct 09, 2002
VITA IN-CERAM YZ CUBES FOR CEREC
K022996 · EIH
Vident
Dental · 30d
Cleared Oct 09, 2002
ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
K023102 · MEH
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Oct 09, 2002
JET-X TIN COATED HALF PINS
K023134 · JDW
Smith & Nephew, Inc.
Orthopedic · 19d
Cleared Oct 09, 2002
NITRILE POWDER-FREE EXAMINATION GLOVES
K023170 · LZA
Allegiance Healthcare Corp.
General Hospital · 16d
Cleared Oct 09, 2002
OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT)
K023207 · LNH
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Oct 09, 2002
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA
K023285 · NHX
Axis-Shield Diagnostics, Ltd.
Immunology · 23d
Cleared Oct 09, 2002
BOSWORTH CORACO-CLAVICULAR SCREW
K023294 · HWC
Howmedica Osteonics Corp.
Orthopedic · 7d
Cleared Oct 09, 2002
OCO DENTAL IMPLANT (5.0MM DIAMETER)
K023336 · DZE
"O" Co., Inc.
Dental · 2d
Cleared Oct 08, 2002
FOCUS RADIATION TREATMENT PLANNING SYSTEM
K020027 · MUJ
Computerized Medical Systems, Inc.
Radiology · 277d
Cleared Oct 08, 2002
OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4
K020507 · GWG
Olympus Winter & Ibe GmbH
Neurology · 235d
Cleared Oct 08, 2002
MODEL 4310 PSARRAY2 EEG ELECTRODE
K020670 · GXY
Physiometrix, Inc.
Neurology · 221d
Cleared Oct 08, 2002
ARTEMIS
K021333 · IYO
Ultralink, LLC
Radiology · 165d
Cleared Oct 08, 2002
SIMPLIFY COMPACT RESUSCITATOR
K021716 · BTM
Polymed (Xiamen) Plastic Industrial...
Anesthesiology · 138d
Cleared Oct 08, 2002
TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES...
K021955 · DQA
Datex-Ohmeda, Inc.
Anesthesiology · 116d
Cleared Oct 08, 2002
ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II,...
K022226 · GEX
Altus Medical, Inc.
General & Plastic Surgery · 90d
Cleared Oct 08, 2002
FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES
K022228 · GEX
Iridex Corp
General & Plastic Surgery · 90d
Cleared Oct 08, 2002
KONRAD, MODEL V.2.0
K022307 · MUJ
Mrc Systems GmbH
Radiology · 84d
Cleared Oct 08, 2002
INNOVA AND INNOVA 2000 S
K022322 · OWB
Ge Medical Systems, Inc.
Radiology · 83d
Cleared Oct 08, 2002
STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K022441 · JOJ
Advanced Sterilization Products
General Hospital · 75d
Cleared Oct 08, 2002
GETTIG DISPOSABLE SYRINGES
K022495 · FMF
Gettig Pharmaceutical Instrument Co.
General Hospital · 71d
Cleared Oct 08, 2002
TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915
K022565 · JAA
Stereotaxis, Inc.
Radiology · 67d
Cleared Oct 08, 2002
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K022656 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 60d