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

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176,076 results
73801–73824 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 2003
CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM
K023689 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 77d
Cleared Jan 17, 2003
VISORB SWIFT
K023710 · GAM
Cp Medical
General & Plastic Surgery · 74d
Cleared Jan 17, 2003
GLUCOSE-SL-C ASSAY, MODEL 257-30
K023739 · CFR
Diagnostic Chemicals , Ltd.
Chemistry · 71d
Cleared Jan 17, 2003
SCULPTURE PLUS NANO-HYBRID COMPOSITE
K023742 · EBF
Pentron Laboratory Technologies
Dental · 71d
Cleared Jan 17, 2003
SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G
K023745 · DTX
Sechrist Industries, Inc.
Cardiovascular · 71d
Cleared Jan 17, 2003
FLASH-LITE II LED DENTAL CURING LIGHT
K023748 · EBZ
Discus Dental, Inc.
Dental · 70d
Cleared Jan 17, 2003
BIPOLAR FORCEPS
K023813 · GEI
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 63d
Cleared Jan 17, 2003
MILLEX VV, GV, AND HV SYRINGE FILTER UNITS
K023892 · BSN
Millipore Corp.
Anesthesiology · 56d
Cleared Jan 17, 2003
AVANT GUARDIAN 101
K024018 · KZE
Avant Medical Corporation
General Hospital · 44d
Cleared Jan 17, 2003
THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM
K024020 · FTC
Theralight, Inc.
General & Plastic Surgery · 43d
Cleared Jan 17, 2003
SURESET 3.0 ML RESERVOIR, MODEL 24-103
K024056 · FRN
Applied Diabetes Research, Incorporated
General Hospital · 39d
Cleared Jan 17, 2003
LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114
K024218 · LKJ
Bio-Rad
Immunology · 25d
Cleared Jan 17, 2003
LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130
K024220 · DHN
Bio-Rad
Immunology · 25d
Cleared Jan 17, 2003
LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113
K024232 · LKJ
Bio-Rad
Immunology · 25d
Cleared Jan 17, 2003
ULTRASOUND SCANNER, TYPE 2400
K024236 · IYN
B & K Medical A/S
Radiology · 25d
Cleared Jan 17, 2003
COALESCENT SURGICAL U-CLIP AND ACCESSORIES
K024366 · FZP
Coalescent Surgical
General & Plastic Surgery · 17d
Cleared Jan 17, 2003
CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371...
K030012 · JHX
Beckman Coulter, Inc.
Chemistry · 15d
Cleared Jan 17, 2003
CPC BY SORING GMBH
K030028 · GEI
Soring GmbH Medizintechnik
General & Plastic Surgery · 14d
Cleared Jan 17, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
K030067 · MJX
Ortho-Clinical Diagnostics
Microbiology · 10d
Cleared Jan 17, 2003
TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER...
K030088 · JJY
Biosite Incorporated
Chemistry · 7d
Cleared Jan 16, 2003
MAYBE?MOM MINI OVULATION MICROSCOPE
K013582 · CEP
Maybe?Mom
Chemistry · 443d
Cleared Jan 16, 2003
STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D
K022976 · DAP
Dade Behring, Inc.
Hematology · 132d
Cleared Jan 16, 2003
MODIFICATION TO STANDARD HUMAN PLASMA
K023141 · JPA
Dade Behring, Inc.
Hematology · 118d
Cleared Jan 16, 2003
RDH-2000
K023213 · EIA
Anodia Systems
Dental · 112d