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
77689–77712 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 2001
EZ-ON CONDOM
K001974 · MOL
Mayer Laboratories
Obstetrics & Gynecology · 482d
Cleared Oct 24, 2001
LIFT VB SPINAL SYSTEM
K010930 · MQP
Medtronic Sofamor Danek, Inc.
Orthopedic · 210d
Cleared Oct 24, 2001
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD
K011056 · QEW
Arrow Intl., Inc.
Cardiovascular · 201d
Cleared Oct 24, 2001
SECUREGUARD RETRACTABLE SAFETY SYRINGE
K012121 · MEG
Safegard Medical Products, Inc.
General Hospital · 110d
Cleared Oct 24, 2001
24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524
K012143 · DRA
Medtronic Cardiac Surgical Products
Cardiovascular · 106d
Cleared Oct 24, 2001
CONFORM SHEETING, MODEL IGEL
K012419 · MDA
Implantech Associates, Inc.
General & Plastic Surgery · 86d
Cleared Oct 24, 2001
CAAS II QVA
K012475 · LLZ
Pie Medical Imaging BV
Radiology · 83d
Cleared Oct 24, 2001
MACHNET CAROTIDS COIL ARRAY ASSEMBLY
K012491 · MOS
Machnet BV
Radiology · 82d
Cleared Oct 24, 2001
PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM
K012673 · DYH
Prime Dental Manufacturing, Inc.
Dental · 71d
Cleared Oct 24, 2001
C.T.M. MOBILITY SCOOTER MODEL # HS-320
K012791 · INI
Warepalmy Enterprise, LLC (Usa)
Physical Medicine · 65d
Cleared Oct 24, 2001
C.T.M. MOBITIY SCOOTER MODEL #HS-360
K012792 · INI
Warepalmy Enterprise, LLC (Usa)
Physical Medicine · 65d
Cleared Oct 24, 2001
MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY...
K012822 · FGE
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 62d
Cleared Oct 24, 2001
COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200
K012832 · LGZ
Nxstage Medical, Inc.
General Hospital · 62d
Cleared Oct 24, 2001
INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820,...
K012864 · FCG
Boston Scientific Corp
Gastroenterology & Urology · 58d
Cleared Oct 24, 2001
XTERRA GT POWER WHEELCHAIR
K012909 · ITI
Invacare Corp.
Physical Medicine · 55d
Cleared Oct 24, 2001
COLLATEK POWDER
K012990 · KGN
Biocore Medical Technologies, Inc.
General & Plastic Surgery · 48d
Cleared Oct 24, 2001
GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE
K013147 · JJX
Bionostics, Inc.
Chemistry · 34d
Cleared Oct 24, 2001
PASS SPINAL SYSTEM
K013191 · MNI
Encore Orthopedics, Inc.
Orthopedic · 30d
Cleared Oct 24, 2001
MODIFIED 650 MAMMOGRAPHY SYSTEM
K013290 · IZH
Lorad, A Hologic Co.
Radiology · 22d
Cleared Oct 23, 2001
HUMI-FLOW, MODEL 6-850-00/ 01/02
K010053 · HIF
Northgate Technologies, Inc.
Obstetrics & Gynecology · 288d
Cleared Oct 23, 2001
TELEPRESS III BLOOD PRESSURE MONITOR, MODEL TPIII
K011058 · DXN
Meridian Medical Technologies , Ltd.
Cardiovascular · 200d
Cleared Oct 23, 2001
ERO50, ORDER-NO.: 2070
K012838 · EJT
Wieland Edelmetalle GmbH & Co.
Dental · 61d
Cleared Oct 23, 2001
EURO 45, ORDER-NO.: 2064
K012840 · EJS
Wieland Edelmetalle GmbH & Co.
Dental · 61d
Cleared Oct 23, 2001
MODIFICATION TO: HL168W TOUCH SCREEN
K013033 · DXN
Health & Life Co., Ltd.
Cardiovascular · 43d