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
69817–69840 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 2004
PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW 3031 AND EW 3032
K033894 · DXN
Matsushita Electric Works, Ltd.
Cardiovascular · 86d
Cleared Mar 11, 2004
PROGREAT
K033913 · KRA
Terumo Medical Corp.
Cardiovascular · 85d
Cleared Mar 11, 2004
ATH FEMORAL STEM
K034028 · JDI
Wrightmedicaltechnologyinc
Orthopedic · 73d
Cleared Mar 11, 2004
FREELITE HUMAN KAPPA AND LAMBDA KITS
K040009 · DFH
The Binding Site, Ltd.
Immunology · 69d
Cleared Mar 11, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -- AMPICILLIN -- GRAM POSITIVE
K040106 · LON
Becton, Dickinson & CO
Microbiology · 51d
Cleared Mar 11, 2004
PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS
K040280 · JJY
Roche Diagnostics Corp.
Chemistry · 34d
Cleared Mar 11, 2004
EL-ANA PROFILES: ANTI-CHROMATIN
K040291 · LJM
Theratest Laboratories, Inc.
Immunology · 34d
Cleared Mar 11, 2004
FLIGHT SOCK
K040353 · DWL
Ssl Americas, Inc.
General Hospital · 28d
Cleared Mar 11, 2004
WBR-FHR, WBR-FWB
K040370 · KPS
Ultraspect , Ltd.
Radiology · 27d
Cleared Mar 11, 2004
AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
K040453 · DRM
Revivant Corp.
Cardiovascular · 17d
Cleared Mar 11, 2004
MEDIPACS
K040486 · LLZ
Neobit Co., Ltd.
Radiology · 15d
Cleared Mar 11, 2004
VITALAB AMYLASE REAGENT
K040534 · JFJ
Clinical Data, Inc.
Chemistry · 9d
Cleared Mar 10, 2004
S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM
K030797 · BZD
ResMed Corp
Anesthesiology · 363d
Cleared Mar 10, 2004
POGS 33
K030920 · CAW
On Site Gas Systems, Inc.
Anesthesiology · 352d
Cleared Mar 10, 2004
DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
K032803 · BSZ
Datex-Ohmeda
Anesthesiology · 183d
Cleared Mar 10, 2004
VIDAPORT INTRAOSSEOUS INFUSION SYSTEM
K032885 · FMI
Vidacare Corporation
General Hospital · 176d
Cleared Mar 10, 2004
DIRECT HDL-CHOLESTEROL LIQUID COLOR
K032932 · LBS
Stanbio Laboratory
Chemistry · 170d
Cleared Mar 10, 2004
PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER
K033080 · CAZ
Portex, Inc.
Anesthesiology · 163d
Cleared Mar 10, 2004
LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 103
K033518 · BZG
Custom Plastic Products
Anesthesiology · 124d
Cleared Mar 10, 2004
STARLUX PULSED LIGHT SYSTEM
K033549 · GEX
Palomar Medical Products, Inc.
General & Plastic Surgery · 119d
Cleared Mar 10, 2004
RESMED S8 PRIME CPAP SYSTEM
K033841 · BZD
Resmed, Ltd.
Anesthesiology · 91d
Cleared Mar 10, 2004
ELECTRO-LUBE
K033880 · GEI
Mectra Labs, Inc.
General & Plastic Surgery · 86d
Cleared Mar 10, 2004
AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10
K033921 · JIF
Diagnostic Chemicals , Ltd.
Chemistry · 83d
Cleared Mar 10, 2004
VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR
K034000 · CDT
Clinical Data, Inc.
Chemistry · 77d