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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
52513–52536 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 2009
SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE...
K083758 · GXY
The Electrode Store, Inc.
Neurology · 240d
Cleared Aug 14, 2009
ASFORA BULLET CAGE SYSTEM
K090048 · MAX
Medical Designs, LLC
Orthopedic · 219d
Cleared Aug 14, 2009
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001
K090332 · NBW
Arkray Factory USA, Inc.
Chemistry · 185d
Cleared Aug 14, 2009
MODIFICATION TO: TSRH SPINAL SYSTEM
K090740 · NKB
Medtronic Sofamor Danek
Orthopedic · 147d
Cleared Aug 14, 2009
B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET
K090995 · CAZ
B.Braun Medical, Inc.
Anesthesiology · 129d
Cleared Aug 14, 2009
ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS
K091123 · JJX
Siemens Healthcare Diagnostics
Chemistry · 119d
Cleared Aug 14, 2009
MEDI-6000 MEDICAL IMAGE DIGITIZER
K091288 · LMA
Microtek International, Inc.
Radiology · 105d
Cleared Aug 14, 2009
DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME...
K091455 · MZV
Diazyme Laboratories
Chemistry · 88d
Cleared Aug 14, 2009
BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE
K091461 · MOD
Cardiopulmonary Corp.
Anesthesiology · 88d
Cleared Aug 14, 2009
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
K091742 · JFY
Beckman Coulter, Inc.
Chemistry · 59d
Cleared Aug 14, 2009
MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000
K091763 · HTN
Instratek, Inc.
Orthopedic · 59d
Cleared Aug 14, 2009
VITEK 2 GRAM NEGATIVE MEROPENEM
K091899 · LON
bioMerieux, Inc.
Microbiology · 50d
Cleared Aug 13, 2009
ANOVA CONTAINMENT DEVICE
K063461 · EZX
Anova Corporation
General & Plastic Surgery · 1002d
Cleared Aug 13, 2009
G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE
K080844 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 505d
Cleared Aug 13, 2009
TT-102
K081246 · FRO
Tissue Technologies Holdings, LLC
General & Plastic Surgery · 469d
Cleared Aug 13, 2009
CHROMA, MODEL: RZ153C
K083382 · MWJ
Scottcare Corporation
Cardiovascular · 272d
Cleared Aug 13, 2009
ILLUSION POWDER FREE EXAM GLOVES, NATURAL COLOR WITH VANILLA SCENT, ORANGE...
K083571 · LYY
Purna Bina Sdn Bhd
General Hospital · 253d
Cleared Aug 13, 2009
TROPAZONE LOTION
K090337 · FRO
Midlothian Laboratories
General & Plastic Surgery · 184d
Cleared Aug 13, 2009
ALMA LASERS ALEX755 MODULE
K090571 · GEX
Alma Lasers , Ltd.
General & Plastic Surgery · 163d
Cleared Aug 13, 2009
IMM DENTAL IRRIGATION TUBING SET
K090727 · EBW
Innovative Medical Manufacturing Co.
Dental · 147d
Cleared Aug 13, 2009
LIGHTLAS SELECTOR
K090774 · HQF
Lightmed Corp.
Ophthalmic · 143d
Cleared Aug 13, 2009
HELIO2 BLENDER
K090781 · BZR
Precision Medical, Inc.
Anesthesiology · 143d
Cleared Aug 13, 2009
FOXQ 980 LASER
K091059 · GEX
A.R.C Laser GmbH
General & Plastic Surgery · 121d
Cleared Aug 13, 2009
UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+
K091238 · CBK
Impact Instrumentation, Inc.
Anesthesiology · 108d