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
46849–46872 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 2011
ATRICURE CRYO MODULE SYSTEM
K112072 · GEH
AtriCure, Inc.
General & Plastic Surgery · 14d
Cleared Aug 02, 2011
SIGMA STERILIZATION POUCH & ROLL
K102158 · FRG
Sigma Medical Supplies Corp.
General Hospital · 368d
Cleared Aug 02, 2011
VANTAGE TITAN 3T
K102489 · LNH
Toshiba Medical Systems Corporation,...
Radiology · 336d
Cleared Aug 02, 2011
UNITED U2 XPE TOTAL KNEE SYSTEM
K103733 · JWH
United Orthopedic Corporation
Orthopedic · 223d
Cleared CT Aug 02, 2011
TRUSIGNAL R SPO2 PEDITIP SENSOR
K103802 · DQA
GE Healthcare Finland Oy
Anesthesiology · 217d
Cleared Aug 02, 2011
DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM
K110679 · NKB
Phygen, LLC
Orthopedic · 145d
Cleared Aug 02, 2011
WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM
K110801 · MQB
Direct Digital Imaging Technology...
Radiology · 132d
Cleared Aug 02, 2011
LO-BAK TRAX
K110858 · HST
Roland F Berthiaume, DC
Neurology · 127d
Cleared Aug 02, 2011
MESA SPINAL SYSTEM (KEYSTONE RODS)
K110991 · MNI
K2m, Inc.
Orthopedic · 116d
Cleared Aug 02, 2011
JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS -...
K111067 · FYA
Kunshan Jiehong Nonwoven Product Co.,...
General Hospital · 106d
Cleared Aug 02, 2011
ARTHREX DISTAL EXTREMITY PLATE SYSTEM
K111253 · HRS
Arthrex, Inc.
Orthopedic · 90d
Cleared Aug 02, 2011
ANCHORWIRE GUIDEWIRE
K111288 · DQX
Lake Region Medical
Cardiovascular · 88d
Cleared Aug 02, 2011
VU C*POD INTERVERTEBRAL BODY FUSION DEVICE
K111675 · ODP
Theken Spine, LLC
Orthopedic · 48d
Cleared Aug 01, 2011
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K101572 · DHB
Siemens Healthcare Diagnostics
Immunology · 423d
Cleared Aug 01, 2011
SYPHILIS HEALTH CHECK
K102400 · LIP
Diagnostics Direct, LLC
Microbiology · 342d
Cleared Aug 01, 2011
BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20
K110383 · BZD
A Plus Medical
Anesthesiology · 172d
Cleared Aug 01, 2011
CURE CATHETER
K110653 · EZD
Cure Medical, LLC
Gastroenterology & Urology · 147d
Cleared Aug 01, 2011
VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES,...
K110958 · FQH
Smith & Nephew, Inc.
General Hospital · 118d
Cleared Aug 01, 2011
INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS)
K111160 · DSI
Intricon Datrix Corporation
Cardiovascular · 98d
Cleared Aug 01, 2011
BENELLI ACCESS DEVICE
K111334 · DQY
Vascular Solutions, Inc.
Cardiovascular · 81d
Cleared Aug 01, 2011
PRIMEWIRE PRESTIGE PLUS
K111395 · DQX
Volcano Corporation
Cardiovascular · 74d
Cleared Aug 01, 2011
B1P ADHESIVE
K111431 · KLE
Pentron Clinical
Dental · 70d
Cleared Aug 01, 2011
A & D MEDICAL UA-1000 FAMILY DAGITAL BLOOD PRESSURE MONITORS
K111686 · DXN
A&D Company, Ltd.
Cardiovascular · 46d
Cleared Aug 01, 2011
KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER
K111745 · DSH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 41d