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
67945–67968 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 30, 2004
AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
K042425 · JLX
Wallac OY
Chemistry · 22d
Cleared Sep 30, 2004
V-CORE FULL CORE BREAST BIOPSY INSTRUMENT
K042464 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 17d
Cleared Sep 30, 2004
PERIFIX CATHETER AND CONTIPLEX CATHETER
K042488 · BSO
B.Braun Medical, Inc.
Anesthesiology · 17d
Cleared Sep 30, 2004
ELECSYS FOLATE II CALSET II
K042490 · JIT
Roche Diagnostics Corp.
Chemistry · 16d
Cleared Sep 30, 2004
AMPLIFE DIGITAL CLINICAL THERMOMETER
K042575 · FLL
Amplife Corporation
General Hospital · 8d
Cleared Sep 29, 2004
P4-FITNESS
K031611 · NGX
Valmed Corp.
Physical Medicine · 496d
Cleared Sep 29, 2004
BARDEX I.C. LATEX FOLEY CATHETER
K040658 · MJC
C.R. Bard, Inc.
Gastroenterology & Urology · 201d
Cleared Sep 29, 2004
THE STRIPPER PGD
K041435 · MQH
Mid-Atlantic Diagnostics, Inc.
Obstetrics & Gynecology · 124d
Cleared Sep 29, 2004
EDWARDS E360 SURGICAL ABLATION DEVICE
K041739 · GEX
Edwards Lifesciences, LLC
General & Plastic Surgery · 93d
Cleared Sep 29, 2004
MAGELLAN RATIO DISPENSER KIT
K041830 · FMF
Medtronic Perfusion Systems
General Hospital · 84d
Cleared Sep 29, 2004
ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA)
K041866 · CDZ
Axis-Shield Diagnostics, Ltd.
Chemistry · 82d
Cleared Sep 29, 2004
ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE
K042015 · CGA
Bayer Healthcare, Diagnostics Division
Chemistry · 64d
Cleared Sep 29, 2004
HOVEROUND POWER WHEELCHAIR, MODEL HD700
K042033 · ITI
Hoveround Corp.
Physical Medicine · 62d
Cleared Sep 29, 2004
SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM
K042277 · LFL
Integra Neurosciences, Ltd.
General & Plastic Surgery · 37d
Cleared Sep 29, 2004
DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D
K042361 · IZL
Sedecal USA, Inc.
Radiology · 29d
Cleared Sep 29, 2004
ARION
K042474 · GEX
Wavelight Laser Technologie AG
General & Plastic Surgery · 16d
Cleared Sep 29, 2004
8600 VITAL SIGNS MONITOR
K042569 · MWI
Criticare Systems, Inc.
Cardiovascular · 8d
Cleared Sep 28, 2004
COSMED PONY FX
K040549 · BTY
Cosmed Srl
Anesthesiology · 210d
Cleared Sep 28, 2004
COOLTOUCH, MODEL NS 160
K040921 · GEX
Cooltouch, Inc.
General & Plastic Surgery · 173d
Cleared Sep 28, 2004
GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103
K041079 · CAF
Guan Hong Enterprise Co., Ltd.
Anesthesiology · 155d
Cleared Sep 28, 2004
FLO-ASSISTANT
K041560 · HIF
Northgate Technologies, Inc.
Obstetrics & Gynecology · 110d
Cleared Sep 28, 2004
LIGASURE PRECISE MODEL #LS1200/LIGASURE 5MM LAPAROSCOPIC SEALER DIVIDER MODEL...
K041587 · GEI
Valleylab
General & Plastic Surgery · 106d
Cleared Sep 28, 2004
COMPASS M10 SYSTEM
K041724 · MNR
Medcare Flaga
Anesthesiology · 96d
Cleared Sep 28, 2004
POLAR WAND
K041783 · GEH
Chek-Med Systems
General & Plastic Surgery · 89d