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
76801–76824 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 03, 2001
MODIFICATION TO: BIOMET HUMERAL CABLE PLATES
K013657 · HRS
Biomet Orthopedics, Inc.
Orthopedic · 27d
Cleared Dec 03, 2001
XPLAN 2.2 WITH THE BODY SYSTEM
K013661 · MUJ
Radionics, A Division of Tyco...
Radiology · 27d
Cleared Dec 03, 2001
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K013772 · LXT
Howmedica Osteonics
Orthopedic · 20d
Cleared Dec 03, 2001
TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS
K013849 · ITX
Tetrad Corp.
Radiology · 13d
Cleared Dec 03, 2001
PAIN CARE 3200
K013928 · MEB
Breg, Inc.
General Hospital · 5d
Cleared Nov 30, 2001
OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)
K011043 · JXA
Osmetech
Microbiology · 239d
Cleared Nov 30, 2001
ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA...
K011479 · CGA
Inverness Medical Innovations, Inc.
Chemistry · 200d
Cleared Nov 30, 2001
INFLUENZA A/B RAPID TEST, CAT NO 2158 663
K011684 · PSZ
Roche Diagnostics Corp.
Microbiology · 184d
Cleared Nov 30, 2001
SERIM BLOOD LEAK TEST STRIP-2
K012115 · FJD
Serim Research Corp.
Gastroenterology & Urology · 147d
Cleared Nov 30, 2001
AMEDITECH IMMUTEST DRUG SCREEN OPIATES
K012483 · DJG
Ameditech, Inc.
Toxicology · 120d
Cleared Nov 30, 2001
AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE
K012484 · DKZ
Ameditech, Inc.
Toxicology · 120d
Cleared Nov 30, 2001
BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST
K012521 · GTZ
Binax, Inc.
Microbiology · 116d
Cleared Nov 30, 2001
AMEDITECH IMMUTEST DRUG SCREEN PCP
K012582 · LCM
Ameditech, Inc.
Toxicology · 112d
Cleared Nov 30, 2001
GIOTTO IMAGE
K012953 · IZH
Medx, Inc.
Radiology · 87d
Cleared Nov 30, 2001
LYMPHA PRESS PLUS DEVICE
K013331 · JOW
Mego Afek
Cardiovascular · 56d
Cleared Nov 30, 2001
IUI, MODEL 4220
K013501 · MQF
Gynetics Medical Products NV
Obstetrics & Gynecology · 39d
Cleared Nov 30, 2001
EMTRAC
K013536 · MQF
Gynetics Medical Products NV
Obstetrics & Gynecology · 38d
Cleared Nov 29, 2001
OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)
K001121 · CBF
Engineered Medical Technology, Inc.
Anesthesiology · 601d
Cleared Nov 29, 2001
MULTISTIM
K011308 · BXN
Pajunk GmbH
Anesthesiology · 213d
Cleared Nov 29, 2001
TINA-QUANT COMPLEMENT C4 TEST SYSTEM
K012359 · DBI
Roche Diagnostics Corp.
Immunology · 127d
Cleared Nov 29, 2001
TINA-QUANT COMPLEMENT C3C TEST SYSTEM
K012361 · CZW
Roche Diagnostics Corp.
Immunology · 127d
Cleared Nov 29, 2001
DRYSTAR, MODEL 4500M
K012941 · LMC
Agfa Corp.
Radiology · 90d
Cleared Nov 29, 2001
NEPTUNE WASTE MANAGEMENT STSTEM
K012991 · FYD
Stryker Instruments
General Hospital · 84d
Cleared Nov 29, 2001
NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
K013049 · LRK
Dennis R. Bailey, Dds
Dental · 79d