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
79633–79656 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 13, 2001
WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE
K011598 · MTW
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 20d
Cleared Jun 13, 2001
TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001
K011693 · FSY
Trumpf Medical Systems, Inc.
General & Plastic Surgery · 13d
Cleared Jun 13, 2001
WORLAND UNICONDYLAR TIBIAL BEARING
K011795 · HRY
Biomet, Inc.
Orthopedic · 5d
Cleared Jun 12, 2001
GERATHERM BABYWATCH TEMPERATURE MONITOR
K001281 · FLL
Geratherm AG
General Hospital · 417d
Cleared Jun 12, 2001
MULTI-STIM, MODEL MS-100
K001897 · GZJ
Metron Medical Australia, Pty, Ltd.
Neurology · 356d
Cleared Jun 12, 2001
AMBULATORY ENTERAL NUTRITION PUMP
K003047 · LZH
Ross Product Div. Abbott Laboratories
General Hospital · 256d
Cleared Jun 12, 2001
MEDCOMP ULTRA-FLOW CATHETER
K003207 · MSD
Medical Components, Inc.
Gastroenterology & Urology · 242d
Cleared Jun 12, 2001
CD HORIZON SPINAL SYSTEM, 4.5 ROD FOR POSTERIOR APPLICATION
K010181 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 144d
Cleared Jun 12, 2001
ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL
K010209 · GZJ
Biomedical Life Systems, Inc.
Neurology · 140d
Cleared Jun 12, 2001
SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE
K010766 · KTT
Synthes (Usa)
Orthopedic · 90d
Cleared Jun 12, 2001
BCI ADVISOR VITAL SIGNS MONITOR (9200)
K010770 · MWI
Bci, Inc.
Cardiovascular · 90d
Cleared Jun 12, 2001
BIOCELLECT
K010775 · LYC
Imtec Corp.
Dental · 90d
Cleared Jun 12, 2001
TROCHANTERIC NAIL
K010780 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 89d
Cleared Jun 12, 2001
HEARTCARD, MODEL 5258
K010945 · DXH
Instromedix
Cardiovascular · 75d
Cleared Jun 12, 2001
ISOLA BAND CLAMP
K010972 · MNI
Depuyacromed
Orthopedic · 71d
Cleared Jun 12, 2001
TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55
K011007 · MBI
Arthrex, Inc.
Orthopedic · 69d
Cleared Jun 12, 2001
NAC PLUS NEEDLELESS ACCESS CONNECTOR
K011193 · FPA
Porex Medical Products
General Hospital · 54d
Cleared Jun 12, 2001
PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK
K011336 · FPA
Churchill Medical Systems, Inc.
General Hospital · 41d
Cleared Jun 12, 2001
MM-87 MOTOR-DRIVE MANIPULATOR
K011420 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 34d
Cleared Jun 12, 2001
BALLERT CRANIAL MOLDING HELMET
K011433 · MVA
Gema, Inc.
Neurology · 33d
Cleared Jun 12, 2001
CD HORIZON SPINAL SYSTEM
K011508 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Jun 12, 2001
T2 HUMERAL NAIL SYSTEM
K011529 · HSB
Howmedica Osteonics Corp.
Orthopedic · 26d
Cleared Jun 12, 2001
EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229
K011605 · LBZ
Syva Co., Dade Behring, Inc.
Toxicology · 19d
Cleared Jun 11, 2001
EN BLOC BIOPSY SYSTEM
K003190 · GEI
Neothermia Corp.
General & Plastic Surgery · 243d