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
119161–119184 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 1991
ANTI-DSDNA ANTIBODY TEST
K913041 · LLL
Helix Diagnostics, Inc.
Immunology · 119d
Cleared Nov 05, 1991
0.016 GUIDE WIRE FOR NEUROLOGICAL ENDOSCOPE
K913074 · DQX
Terumo Medical Corp.
Cardiovascular · 117d
Cleared Nov 05, 1991
APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501
K913098 · KNW
Dlp, Inc.
Gastroenterology & Urology · 116d
Cleared Nov 05, 1991
VARIAN CLINAC 600SR
K913174 · IYE
Varian Assoc., Inc.
Radiology · 125d
Cleared Nov 05, 1991
IN-THE-EAR HEARING AIDS
K913366 · ESD
Fenwick Hearing Instruments
Ear, Nose, Throat · 99d
Cleared Nov 05, 1991
TEGWIRE (TM)
K913391 · LIT
Boston Scientific Corp
Cardiovascular · 98d
Cleared Nov 05, 1991
ELECTROSURGICAL UNIT CABLE
K913514 · GEI
Kirwan Surgical Products, Inc.
General & Plastic Surgery · 90d
Cleared Nov 05, 1991
ISOLATE INFUSION CATHETR SYSTEM
K913517 · DQY
Lake Region Mfg., Inc.
Cardiovascular · 90d
Cleared Nov 05, 1991
MILESTONE MS 325 RADIOGRAPHIC X-RAY GENERATOR
K913577 · IZO
Control-X, Inc.
Radiology · 85d
Cleared Nov 05, 1991
EARSCAN DSP-1 PURE TONE AUDIOMETER
K913589 · EWO
Micro Audiometrics Corp.
Ear, Nose, Throat · 85d
Cleared Nov 05, 1991
AUTOMATIC CORNEAL SHAPER
K913697 · HNO
Hansa Research & Development, Inc.
Ophthalmic · 78d
Cleared Nov 05, 1991
STAYFREE(TM) MAXI-PAD
K913747 · HHD
Personal Products Co.
Obstetrics & Gynecology · 76d
Cleared Nov 05, 1991
ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32
K913764 · JGJ
Em Diagnostic Systems, Inc.
Chemistry · 75d
Cleared Nov 05, 1991
FLEXIFLO OVER-THE-GUIDEWIRE GAST KIT W/CR-BAR BUMP
K913786 · KNT
Abbott Laboratories
Gastroenterology & Urology · 74d
Cleared Nov 05, 1991
MICROSCIS(TM) INTROCULAR SCISSOR SYSTEM
K913837 · HQE
Vision Medical, Inc.
Ophthalmic · 71d
Cleared Nov 05, 1991
X-RAY TABLE
K914165 · IXR
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Nov 05, 1991
GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE
K914447 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 32d
Cleared Nov 05, 1991
GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE
K914448 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 32d
Cleared Nov 05, 1991
GORE-TEX(R) SURGICAL MEMBRANE, PROCESS CHANGE
K914450 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 32d
Cleared Nov 05, 1991
HEARING AID, UNITRON MODEL VISTA 3000
K914688 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 18d
Cleared Nov 05, 1991
HEARING AID, UNITRON MODEL VISTA 4000
K914689 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 18d
Cleared Nov 05, 1991
COORDINATOR, CABLE INPUT
K914725 · DPS
Cardiotronics, Inc.
Cardiovascular · 15d
Cleared Nov 05, 1991
P54 BTE HEARING AID
K914800 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 13d
Cleared Nov 04, 1991
XKNIFE RADIOSURGERY SYSTEM
K912630 · IYE
Rsa, Inc.
Radiology · 140d