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
69865–69888 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 09, 2004
MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL
K040348 · MOS
Mri Devices Corp.
Radiology · 26d
Cleared Mar 09, 2004
MODIFICATION TO HRW-127 WRIST ARRAY COIL
K040349 · MOS
Mri Devices Corp.
Radiology · 26d
Cleared Mar 09, 2004
FLEBOSET MULTIPLE
K040456 · LHI
Laboratorios Grifols, S.A.
General Hospital · 15d
Cleared Mar 09, 2004
SONOLINE EBISU DIAGNOSTIC ULTRASOUND SYSTEMS
K040502 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 11d
Cleared Mar 08, 2004
SMART KLAMP VARIOUS BY SIZE
K032091 · HFX
Emergogroup, Inc.
Obstetrics & Gynecology · 245d
Cleared Mar 08, 2004
ZTI IMPLANTS SYSTEM, DRM IMPLANTS
K034067 · DZE
Drm Research Laboratories, Inc.
Dental · 68d
Cleared Mar 08, 2004
AMEDITECH IMMU TEST DRUG SCREEN PANEL
K040092 · DKZ
Ameditech, Inc.
Toxicology · 52d
Cleared Mar 08, 2004
QUANTA PLEX SLE PROFILE 8
K040160 · LLL
Inova Diagnostics, Inc.
Immunology · 45d
Cleared Mar 08, 2004
PANORET, MODEL PNM 60
K040325 · HKI
Medibell Medical Vision Technologies...
Ophthalmic · 27d
Cleared Mar 08, 2004
MODIFICATION TO E.P.T. PREGNANCY TEST
K040329 · LCX
Unipath , Ltd.
Chemistry · 26d
Cleared Mar 08, 2004
CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST
K040341 · LCX
Unipath , Ltd.
Chemistry · 25d
Cleared Mar 08, 2004
VITALAB URIC ACID REAGENT
K040467 · KNK
Clinical Data, Inc.
Chemistry · 13d
Cleared Mar 08, 2004
VITALAB MAGNESIUM REAGENT
K040508 · JGJ
Clinical Data, Inc.
Chemistry · 10d
Cleared Mar 05, 2004
ALLOMATRIX MODEL# 86
K020895 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 717d
Cleared Mar 05, 2004
DYNESYS SPINAL SYSTEM
K031511 · NQP
Centerpulse Spine-Tech, Inc.
Orthopedic · 296d
Cleared Mar 05, 2004
AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE
K032278 · GXY
Ambu, Inc.
Neurology · 225d
Cleared Mar 05, 2004
COLONOSIGHT MODEL 510B
K032688 · FDF
Sightline Technologies , Ltd.
Gastroenterology & Urology · 189d
Cleared Mar 05, 2004
I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2
K033136 · LPL
Innova Vision, Inc.
Ophthalmic · 157d
Cleared Mar 05, 2004
PAJUNK MODULAR HANDLE INSTRUMENTS
K033249 · GCJ
Pajunk GmbH
General & Plastic Surgery · 150d
Cleared Mar 05, 2004
TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002
K033410 · DXH
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 130d
Cleared Mar 05, 2004
NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM
K033810 · HRY
Centerpulse Orthopedics, Inc.
Orthopedic · 88d
Cleared Mar 05, 2004
SPI CONTACT DENTAL IMPLANT
K034014 · DZE
Thommen Medical AG
Dental · 72d
Cleared Mar 05, 2004
TI CLIP APPLIER
K034029 · NJC
Gyrx, LLC
General & Plastic Surgery · 67d
Cleared Mar 05, 2004
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG...
K040095 · MVM
Immco Diagnostics, Inc.
Immunology · 45d