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

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175,820 results
42409–42432 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 2012
LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT
K123663 · JJY
Bio-Rad Laboratories
Chemistry · 29d
Cleared Dec 27, 2012
NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR
K123683 · MXA
Aerocrine AB
Chemistry · 27d
Cleared Dec 26, 2012
STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324
K123017 · FRC
Advanced Sterilization Products
General Hospital · 89d
Cleared Dec 21, 2012
DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS
K112898 · LPH
Lima Corporate S.P.A.
Orthopedic · 445d
Cleared Dec 21, 2012
FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR
K113010 · IPF
Famidoc Technology Co., Ltd.
Physical Medicine · 437d
Cleared Dec 21, 2012
STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER
K113023 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 437d
Cleared Dec 21, 2012
MR4500 WHEELCHAIR
K120391 · IOR
Wardray Premise, Ltd.
Physical Medicine · 318d
Cleared Dec 21, 2012
ANESTHESIA CONDUCTION NEEDLES
K120475 · BSP
Shanghai Samedical & Plastic...
Anesthesiology · 309d
Cleared Dec 21, 2012
Z-LOOK3 EVO SLM
K120793 · DZE
Z-Systems AG
Dental · 281d
Cleared Dec 21, 2012
STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT...
K120822 · NHA
Institut Straumann AG
Dental · 277d
Cleared Dec 21, 2012
PREXION 3D
K120948 · OAS
The Yoshida Dental Mfg. Co., Ltd.
Radiology · 267d
Cleared Dec 21, 2012
ABBOTT PLEX-ID FLU ASSAY
K121003 · OCC
Abbott Laboratories
Microbiology · 263d
Cleared Dec 21, 2012
NHANCER
K121077 · DQY
Imds Operations B.V.
Cardiovascular · 256d
Cleared Dec 21, 2012
CENTURION VISION SYSTEM
K121555 · HQC
Alcon Laboratories, Inc.
Ophthalmic · 210d
Cleared Dec 21, 2012
SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED...
K122106 · JAK
Veran Medical Technologies, Inc.
Radiology · 157d
Cleared Dec 21, 2012
GLOOKO LOGBOOK CHARTS
K122142 · NBW
Glooko, Inc.
Chemistry · 155d
Cleared Dec 21, 2012
AB COMMAND DUAL CHANNEL FITNESS BELT
K122414 · NGX
Leto Enterprises Incorporation
Physical Medicine · 135d
Cleared Dec 21, 2012
VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003
K122609 · JOW
Venous Health Systems, Inc.
Cardiovascular · 116d
Cleared Dec 21, 2012
PANTHER OIS/R & V MODEL VERSION 2.0
K122616 · IYE
Prowess, Inc.
Radiology · 116d
Cleared Dec 21, 2012
ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE
K122690 · CAZ
Arrow International, Inc.
Anesthesiology · 108d
Cleared Dec 21, 2012
FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK
K122717 · FXX
Tiger Medical Products, Ltd.
General Hospital · 107d
Cleared Dec 21, 2012
SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646
K122897 · MOS
Invivo Corporation
Radiology · 91d
Cleared Dec 21, 2012
GEMORE TRUE SINE INTERFERENTIAL STIMULATOR
K122944 · LIH
Gemore Technology Co, Ltd.
Neurology · 88d
Cleared Dec 21, 2012
GEM-STIM COMBO STIMULATOR
K122948 · GZJ
Gemore Technology Co, Ltd.
Neurology · 88d