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
66409–66432 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 2005
ACCUHEART ELECTRODE BELT
K043361 · DRX
Advanced Bioelectric Corporation
Cardiovascular · 105d
Cleared Mar 22, 2005
TRIAGE TOX DRUG SCREEN CONTROLS
K050037 · DIF
Biosite Incorporated
Chemistry · 74d
Cleared Mar 22, 2005
12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200
K050074 · DPS
Welch Allyn, Inc.
Cardiovascular · 69d
Cleared Mar 22, 2005
MODIFICATION TO: EXPORT CATHETER
K050139 · QEZ
Medtronic Vascular
Cardiovascular · 60d
Cleared Mar 22, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GP) 0.5-64 UG/ML
K050400 · LON
Becton, Dickinson & CO
Microbiology · 34d
Cleared Mar 22, 2005
VOYAGER PERSONAL IMAGING DEVICE
K050551 · IYO
Ardent Sound, Inc.
Radiology · 19d
Cleared Mar 22, 2005
GS-128 GRADIENT COMPRESSION SYSTEM
K050584 · JOW
Medmark Technologies, LLC
Cardiovascular · 15d
Cleared Mar 22, 2005
LIFESTENT TURBO BILIARY STENT SYSTEMS
K050627 · FGE
Edwards Lifesciences, LLC
Gastroenterology & Urology · 11d
Cleared Mar 22, 2005
PIVOT STEERABLE MICROCATHETER
K050630 · KRA
Boston Scientific - Precision Vascular
Cardiovascular · 11d
Cleared Mar 21, 2005
KD-575 MEMORY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K042418 · DXN
Kodon(Tianjin)Electronic&Electrical...
Cardiovascular · 199d
Cleared Mar 21, 2005
BASS ANTALGIC-TRAK
K042482 · ITH
Traction Masters, LLC
Physical Medicine · 189d
Cleared Mar 21, 2005
CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8
K042999 · DQK
Biosense Webster, Inc.
Cardiovascular · 140d
Cleared Mar 21, 2005
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K043488 · NKB
Medtronic Sofamor Danek
Orthopedic · 94d
Cleared Mar 21, 2005
AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OV
K043497 · EFB
J. Morita USA, Inc.
Dental · 94d
Cleared Mar 21, 2005
MODIFICATION TO: RESTORATION MODULAR SYSTEM
K050138 · JDI
Howmedica Osteonics Corp.
Orthopedic · 59d
Cleared Mar 21, 2005
PERIOSCAN ULTRASONIC SCALER
K050354 · ELC
Sirona Dental Systems GmbH
Dental · 35d
Cleared Mar 21, 2005
STRYKER LOCKED PLATING SYSTEM
K050512 · HRS
Howmedica Osteonics Corp.
Orthopedic · 20d
Cleared Mar 21, 2005
MODIFICATION TO: ARTHREX V-TAK
K050634 · HWC
Arthrex, Inc.
Orthopedic · 12d
Cleared Mar 18, 2005
UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS
K033577 · KPR
Medlink Imaging
Radiology · 491d
Cleared Mar 18, 2005
TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES)
K041311 · BTR
Tiger Medical Products, Ltd.
Anesthesiology · 305d
Cleared Mar 18, 2005
ISIS MER SYSTEM/ELEKTA MER SYSTEM
K042208 · GZL
Inomed Medizintechnik GmbH
Neurology · 214d
Cleared Mar 18, 2005
RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM,...
K042523 · FJL
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 182d
Cleared Mar 18, 2005
POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A
K042727 · CBP
Foremount Ent. Co., Ltd.
Anesthesiology · 168d
Cleared Mar 18, 2005
ACCU-CHEK SPIRIT
K042887 · LZG
Disetronic Medical Systems AG
General Hospital · 150d