Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
79969–79992 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 11, 2001
R & D 4K RETIC
K010470 · JPK
R&D Systems, Inc.
Hematology · 80d
Cleared May 11, 2001
CG-900P FETAL/MATERNAL MONITOR
K010552 · HGM
Card Guard Scientific Survival , Ltd.
Obstetrics & Gynecology · 74d
Cleared May 11, 2001
POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR
K010803 · LYY
Hwa Teh Industrial Sdn. Bhd.
General Hospital · 56d
Cleared May 11, 2001
AMYSEAT TILT/RECLINE SEATING
K011006 · ITI
Amysystems
Physical Medicine · 37d
Cleared May 11, 2001
REGAL MOTOTRIZED 3 WHEELED VEHICLE
K011227 · ITI
Bruno Independent Living Aids, Inc.
Physical Medicine · 18d
Cleared May 10, 2001
CRP HS TEST SYSTEM
K003400 · DCN
Roche Diagnostics Corp.
Immunology · 190d
Cleared May 10, 2001
IMMUNETICS C6 LYME ELISA KIT
K003754 · LSR
Immunetics, Inc.
Microbiology · 156d
Cleared May 10, 2001
ITI DENTAL IMPLANT SYSTEM
K010291 · DZE
Straumann USA
Dental · 99d
Cleared May 10, 2001
THE MAESTRO SYSTEM
K010458 · DZE
BioHorizons Implant Systems, Inc.
Dental · 83d
Cleared May 10, 2001
BECKMAN COULTER DNASE B CALIBRATOR
K010696 · JIS
Beckman Coulter, Inc.
Immunology · 63d
Cleared May 10, 2001
BRIDGE III RECEIVER
K010794 · DXH
Meridian Medical Technologies , Ltd.
Cardiovascular · 55d
Cleared May 10, 2001
DENTO-PREP PARTICLE MICROBLASTER
K010816 · KOJ
Ronvig A/S
Dental · 52d
Cleared May 10, 2001
UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING...
K010879 · LYY
N.S. Uni-Gloves Sdn. Bhd.
General Hospital · 48d
Cleared May 10, 2001
RD-3008
K011036 · EJT
Heraeus Kulzer, Inc.
Dental · 35d
Cleared May 10, 2001
MANDREL GUIDEWIRE ASSEMBLY
K011084 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 30d
Cleared May 10, 2001
MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229
K011163 · JXN
Syva Co., Dade Behring, Inc.
Chemistry · 24d
Cleared May 10, 2001
MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229
K011164 · KXS
Syva Co., Dade Behring, Inc.
Toxicology · 24d
Cleared May 10, 2001
MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229
K011166 · KLS
Syva Co., Dade Behring, Inc.
Chemistry · 24d
Cleared May 09, 2001
MP3HD BIG BOY, POWER WHEELCHAIR
K010380 · ITI
Merits Health Products., Inc.
Physical Medicine · 90d
Cleared May 09, 2001
RUSCH MMG/O'NEIL CATHETER
K010420 · FCM
Rusch, Inc.
Gastroenterology & Urology · 86d
Cleared May 09, 2001
RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM
K010633 · HWC
Mitek Products
Orthopedic · 68d
Cleared May 09, 2001
INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND...
K011065 · FFK
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 30d
Cleared May 09, 2001
ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22)
K011077 · KNT
Andersen Products, Inc.
Gastroenterology & Urology · 30d
Cleared May 08, 2001
ENVOY PATIENT MONITOR
K001120 · DSI
Mennen Medical , Ltd.
Cardiovascular · 396d