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
80041–80064 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 2000
TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL...
K003036 · KYG
Retinalabs.Com
Ophthalmic · 84d
Cleared Dec 22, 2000
FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING
K003134 · KGN
Adri/Technam
General & Plastic Surgery · 77d
Cleared Dec 22, 2000
SYNCHRON SYSTEMS AMMONIA REAGENT
K003196 · JIF
Beckman Coulter, Inc.
Chemistry · 71d
Cleared Dec 22, 2000
EHC400 DESKTOP PATIENT STATION
K003257 · CGA
Cybercare Technologies, Inc.
Chemistry · 65d
Cleared Dec 22, 2000
CLEANAIR/ CLEANWATER UNIT, MODEL 1600
K003265 · EIA
Texas Institute For Conservative...
Dental · 65d
Cleared Dec 22, 2000
PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067
K003270 · JAQ
Nucletron Corp.
Radiology · 65d
Cleared Dec 22, 2000
PEDIATRIC INGESTASCAN
K003305 · HPM
Adams Electronics, Inc.
Ophthalmic · 63d
Cleared Dec 22, 2000
MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL
K003366 · MOS
Igc-Medical Advances, Inc.
Radiology · 53d
Cleared Dec 22, 2000
DW 276 #3
K003635 · EJT
Ivoclar North America, Inc.
Dental · 28d
Cleared Dec 22, 2000
MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL
K003685 · MOS
Medical Advances, Inc.
Radiology · 22d
Cleared Dec 22, 2000
VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II...
K003687 · DKE
Medtox Diagnostics, Inc.
Toxicology · 22d
Cleared Dec 22, 2000
ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES, MODEL 87
K003769 · KGO
Ansell Healthcare Products, Inc.
General Hospital · 16d
Cleared Dec 22, 2000
DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000,...
K003790 · GCJ
Davol, Inc.
General & Plastic Surgery · 14d
Cleared Dec 22, 2000
GE ADVANCE NXI PET SYSTEM
K003849 · KPS
Ge Medical Systems, Inc.
Radiology · 10d
Cleared Dec 22, 2000
PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)
K994279 · FIP
Pure Water Solutions, Inc.
Gastroenterology & Urology · 368d
Cleared Dec 21, 2000
VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER BLOOD...
K000714 · FMI
Med-Pro Technologies, Inc.
General Hospital · 294d
Cleared Dec 21, 2000
CARDIOSENTRY EVENT MONITOR, MODEL 8470-01
K001634 · DXH
Tz Medical, Inc.
Cardiovascular · 209d
Cleared Dec 21, 2000
VECTOR
K002122 · ELC
Air Techniques, Inc.
Dental · 161d
Cleared Dec 21, 2000
MEDIADENT HDX/MMD HDX SP XRAY SENSOR
K002425 · MUH
Multi Media Dental Systems, Inc.
Radiology · 135d
Cleared Dec 21, 2000
RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS
K002954 · DXQ
Rudolf Riester GmbH & Co. KG
Cardiovascular · 90d
Cleared Dec 21, 2000
EMPIRE N BLOOD PRESSURE MANOMETERS
K002955 · DXQ
Rudolf Riester GmbH & Co. KG
Cardiovascular · 90d
Cleared Dec 21, 2000
MAGNETIC CONCERTO
K003192 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 70d
Cleared Dec 21, 2000
SIEMENS INFINITY MODULAR MONITORS MODEL SC 8000
K003243 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 65d
Cleared Dec 21, 2000
SIEMENS MULTI VIEW WORKSTATION WITH VENT VIEWER OPTION
K003246 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 65d