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
72481–72504 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 11, 2003
RESQPOD CIRCULATORY ENHANCER
K022906 · BWF
Cprx, LLC
Anesthesiology · 281d
Cleared Jun 11, 2003
GALIX PACESTAR
K023080 · DTE
Galix Biomedical Instrumentation, Inc.
Cardiovascular · 267d
Cleared Jun 11, 2003
DISPOSABLE TEMPORARY PACING WIRE
K023174 · LDF
River Medical, Inc.
Cardiovascular · 261d
Cleared Jun 11, 2003
DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER
K024010 · EZL
The Kendall Company Div. of Tyco...
Gastroenterology & Urology · 189d
Cleared Jun 11, 2003
VECTORVISION FLUORO3D
K024192 · HAW
Brainlab AG
Neurology · 203d
Cleared Jun 11, 2003
PRIME ECG SYSTEM
K030104 · DPS
Meridian Medical Technologies, Inc.
Cardiovascular · 149d
Cleared Jun 11, 2003
EKGCARD SYSTEM
K030535 · DPS
Qrs Diagnostic, LLC
Cardiovascular · 111d
Cleared Jun 11, 2003
ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES
K030800 · GXY
Eletromed, Inc.
Neurology · 90d
Cleared Jun 11, 2003
IQMARK DIGITAL HOLTER
K031466 · MLO
Brentwood Medical Technology Corp.
Cardiovascular · 34d
Cleared Jun 11, 2003
PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS
K031495 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 29d
Cleared Jun 11, 2003
NANO-TICROWN
K031627 · EJH
Nano-Write Corp.
Dental · 15d
Cleared Jun 11, 2003
CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C
K031633 · MQB
Canon USA, Inc.
Radiology · 15d
Cleared Jun 10, 2003
SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000
K021360 · KXK
Med-Tec,Inc.
Radiology · 406d
Cleared Jun 10, 2003
WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE...
K023755 · FXX
Winner Industries (Shenzhen) Co., Ltd.
General Hospital · 214d
Cleared Jun 10, 2003
ASTRA TECH IMPLANTS-DENTAL SYSTEM FIXTURE OSSEOSPEED
K024111 · DZE
Astra Tech, Inc.
Dental · 179d
Cleared Jun 10, 2003
INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST
K024360 · LYR
Alfa Scientific Designs, Inc.
Microbiology · 162d
Cleared Jun 10, 2003
WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS...
K030519 · JEC
Hand Biomechanics Lab, Inc.
Orthopedic · 111d
Cleared Jun 10, 2003
CONTEC LIGHT
K030641 · EBZ
Dentaurum
Dental · 102d
Cleared Jun 10, 2003
COOL CURE
K030811 · EBZ
Samm, Inc.
Dental · 89d
Cleared Jun 10, 2003
POWDERED VINYL EXAM GLOVES, WHITE
K031104 · LYZ
Glormed Intl., Inc.
General Hospital · 64d
Cleared Jun 10, 2003
DISPOSABLE POWDER FREE VINYL EXAM GLOVES
K031113 · LYZ
Elite International, Inc.
General Hospital · 63d
Cleared Jun 10, 2003
KLINIDRAPE SURGICAL DRAPES
K031131 · KKX
Molnlycke Health Care
General Hospital · 62d
Cleared Jun 10, 2003
HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY
K031348 · NHG
Salimetrics, LLC
Chemistry · 60d
Cleared Jun 10, 2003
DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX
K031569 · DSP
Datascope Corp.
Cardiovascular · 21d