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
68185–68208 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 07, 2004
SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21
K041883 · MKJ
Leonhard Lang GmbH
Cardiovascular · 57d
Cleared Sep 07, 2004
COMPASS F10 SYSTEM
K041904 · MNR
Medcare Flaga
Anesthesiology · 54d
Cleared Sep 07, 2004
EN-BLOC BIOPSY SYSTEM...
K042170 · GEI
Neothermia Corporation
General & Plastic Surgery · 27d
Cleared Sep 07, 2004
MODEL 6416 TEMPORARY PACING LEAD SYSTEM
K042190 · LDF
Medtronic Vascular
Cardiovascular · 26d
Cleared Sep 07, 2004
PHOT-X II, MODEL 303
K042260 · EHD
Takara Belmont USA, Inc.
Radiology · 15d
Cleared Sep 03, 2004
MALLARD MODEL 3000 ANESTHESIA MACHINE
K033026 · BSZ
Mallard Medical, Inc.
Anesthesiology · 343d
Cleared Sep 03, 2004
OUTOLOGOUS SPINAL FIXATION SYSTEM
K040493 · MNI
Orthopedic Sciences, Inc.
Orthopedic · 190d
Cleared Sep 03, 2004
MANTRA TENS MODEL NT3
K041520 · GZJ
Mantra Intl. (Hk) , Ltd.
Neurology · 88d
Cleared Sep 03, 2004
CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR
K041627 · NDY
Dako A/S
Chemistry · 79d
Cleared Sep 03, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K041777 · MNI
Medtronic Sofamor Danek
Orthopedic · 64d
Cleared Sep 03, 2004
ALL SAFE HUBER SAFETY INFUSION SETS
K041844 · FPA
Nexus Medical, LLC
General Hospital · 57d
Cleared Sep 03, 2004
OTOGRAM
K041853 · ETW
Tympany, Inc.
Ear, Nose, Throat · 57d
Cleared Sep 03, 2004
ULTRAVISUAL
K042008 · LLZ
Emageon Uv, Inc.
Radiology · 39d
Cleared Sep 03, 2004
PROTENS ELECTRODE
K042301 · GXY
Bio Protech, Inc.
Neurology · 9d
Cleared Sep 02, 2004
PATHFINDER
K031788 · MXK
Massie Research Laboratories, Inc.
Ophthalmic · 450d
Cleared Sep 02, 2004
STRYKER SWITCHPOINT INFINITY
K033132 · GCJ
Stryker Communications Corp.
General & Plastic Surgery · 338d
Cleared Sep 02, 2004
DETECT SURGICAL PACING AND MAPPING TOOL
K040812 · LDF
Medtronic Vascular
Cardiovascular · 157d
Cleared Sep 02, 2004
DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500
K040831 · DPZ
Datex-Ohmeda, Inc.
Anesthesiology · 155d
Cleared Sep 02, 2004
ORALIEF THERAPY FOR SENSITIVE TEETH
K040858 · LBH
Novamin Technology, Inc.
Dental · 153d
Cleared Sep 02, 2004
CADENCE, MODELS 2001 AND 2002
K040903 · HGM
Edan Instruments, Inc.
Obstetrics & Gynecology · 148d
Cleared Sep 02, 2004
ASPIRATION PUMP, MODEL IMD-020
K041405 · BTA
Industrial & Medical Design, Inc.
General & Plastic Surgery · 99d
Cleared Sep 02, 2004
TARGETSCAN BIOPSY KIT
K041638 · ITX
Envisioneering, LLC
Radiology · 77d
Cleared Sep 02, 2004
TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM
K041639 · IYO
Envisioneering, LLC
Radiology · 77d
Cleared Sep 02, 2004
FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS...
K041647 · DQA
Elekon Industries U.S.A., Inc.
Anesthesiology · 77d