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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
46177–46200 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 2011
SAPIENS TIP CONFIRMATION SYSTEM
K112744 · LJS
C.R. Bard, Inc.
General Hospital · 29d
Cleared Oct 20, 2011
EASTLYTE NA/K/CA/PH
K112788 · CEM
Medica Corp.
Chemistry · 24d
Cleared Oct 20, 2011
PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K112974 · LLZ
Curve Dental, Inc.
Radiology · 15d
Cleared CT Oct 19, 2011
SCANVIEW SYSTEM
K110345 · NTH
Applied Spectral Imaging
Pathology · 257d
Cleared Oct 19, 2011
AMT G-J TUBE
K110804 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 211d
Cleared Oct 19, 2011
SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY...
K111766 · FGE
Idev Technologies, Inc.
Gastroenterology & Urology · 118d
Cleared Oct 19, 2011
TBD
K112098 · OOE
Lensar, Inc.
Ophthalmic · 89d
Cleared Oct 18, 2011
DASH HIP
K110021 · OLO
Brainlab AG
Orthopedic · 288d
Cleared Oct 18, 2011
EVERYWAY LOW BACK PAIN RELIEF SYSTEM
K110716 · NUH
Everyway Medical Instruments Co.,Ltd
Neurology · 217d
Cleared Oct 18, 2011
SMARTLOC SPINAL FIXATION SYSTEM
K111883 · MNI
A-Spine Asia, Co., Ltd.
Orthopedic · 109d
Cleared Oct 18, 2011
ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE...
K111904 · LAO
ARK Diagnostics, Inc.
Toxicology · 105d
Cleared Oct 18, 2011
VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE
K111909 · LON
bioMerieux, Inc.
Microbiology · 105d
Cleared Oct 18, 2011
RADIOACTIVE SEED LOCALIZATION NEEDLE
K111979 · KXK
Biocompatibles, Inc.
Radiology · 98d
Cleared Oct 18, 2011
CARDIA-CATH
K112323 · DXO
Millar Instruments, Inc.
Cardiovascular · 67d
Cleared Oct 18, 2011
ABDOMINAL TOURNIQUET SYSTEM
K112384 · DXC
Compression Works, LLC
Cardiovascular · 61d
Cleared Oct 18, 2011
ELECSYS T4 CALCHECK 5
K112528 · JJX
Roche Diagnostics Corporation
Chemistry · 48d
Cleared Oct 18, 2011
CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)
K112586 · JTN
Becton, Dickinson and Company (BD)
Microbiology · 42d
Cleared Oct 18, 2011
V-14 CONTROL WIRE GUIDEWIRE
K112745 · DQX
Boston Scientific Corporation
Cardiovascular · 27d
Cleared Oct 18, 2011
APCLO PEDICLE SCREW SYSTEMS
K112759 · NKB
Atlas Spine, Inc.
Orthopedic · 26d
Cleared Oct 18, 2011
CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION...
K112893 · FPA
Baxter Healthcare Corporation
General Hospital · 15d
Cleared Oct 18, 2011
THERMOFLASH(TM) INFRARED THERMOMETER
K112929 · FLL
Visiomed Group SA
General Hospital · 15d
Cleared Oct 17, 2011
PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES
K103598 · MBH
Wrightmedicaltechnologyinc
Orthopedic · 313d
Cleared Oct 17, 2011
27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+...
K110951 · HQB
Alcon Research, Ltd.
Ophthalmic · 196d
Cleared Oct 17, 2011
SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING
K111311 · MUJ
Omisa Inc. (Segasist Technologies)
Radiology · 160d