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
148225–148248 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 1985
ALLIS TISSUE FORCEPS, 4X5 TEETH, 6+SS 410 OR 420
K852726 · KOA
The Huxley Instrument Corp.
Gastroenterology & Urology · 13d
Cleared Jul 08, 1985
TRINDIUM-DENTAL MATERIAL
K850084 · EJH
Trindium Corp. of America
Dental · 179d
Cleared Jul 08, 1985
CYBERMEDIC CM-810 BODY PLETHYSMOGRAPH
K851197 · JEH
Cybermedic, Inc.
Anesthesiology · 104d
Cleared Jul 08, 1985
LEGIONELLA CULTURE CONFIRMATIN KIT
K851271 · GRO
Gen-Probe, Inc.
Microbiology · 98d
Cleared Jul 08, 1985
BODY ANALYSIS SYSTEM (DEEMED SE 87/09/18)
K851415 · DSB
Medi-Sport Testing, Inc.
Cardiovascular · 90d
Cleared Jul 08, 1985
NEBULAIRE (IRC 1040) NEBULIZER PUMP
K851436 · CAF
Invacare Corp.
Anesthesiology · 89d
Cleared Jul 08, 1985
LPA-3 PRINTER
K851805 · BZC
Life Products, Inc.
Anesthesiology · 69d
Cleared Jul 08, 1985
LPA-2 REMOTE ALARM
K851905 · CAP
Life Products, Inc.
Anesthesiology · 69d
Cleared Jul 08, 1985
RESUS-AID DISPOSABLE RESUSCITATION SHIELD
K852096 · BTM
Emergency Situation Products
Anesthesiology · 55d
Cleared Jul 08, 1985
BIVONA TRACHEOSTOMA VALVE II
K852272 · BTO
Bivona Medical Technologies
Anesthesiology · 41d
Cleared Jul 08, 1985
DURAZYME UREA NITROGEN
K852292 · CDQ
American Monitor Corp.
Chemistry · 40d
Cleared Jul 08, 1985
HDL CHOLESTEROL PRETREATMENT
K852350 · LBR
American Monitor Corp.
Chemistry · 38d
Cleared Jul 08, 1985
ANDROS ANALYZERS AIRWAY ADAPTER
K852463 · CCK
Andros Analyzers, Inc.
Anesthesiology · 28d
Cleared Jul 08, 1985
UNCUFFED HI-LO JET TRACHEAL TUBE
K852493 · BTR
Mallinckrodt Critical Care
Anesthesiology · 26d
Cleared Jul 08, 1985
SERVO HUMIDIFIER 153
K852601 · BYD
Siemens Elema AB
Anesthesiology · 19d
Cleared Jul 05, 1985
DERATA MEDI-JECTOR PRO
K844244 · KZE
Derata Corp.
General Hospital · 246d
Cleared Jul 05, 1985
CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE
K850147 · FRO
Beiersdorf, Inc.
General & Plastic Surgery · 172d
Cleared Jul 05, 1985
BARD OCCLUSIVE WOUND DRESSING
K850889 · FRO
C.R. Bard, Inc.
General & Plastic Surgery · 123d
Cleared Jul 05, 1985
LATEX AGGLUTINATION TEST
K851132 · GTZ
New Horizons Diagnostics Co.
Microbiology · 106d
Cleared Jul 05, 1985
TELET-LEX MEDICAL IV CATHETER PLACEMENT
K851142 · FOZ
Teleflexmedical, Inc.
General Hospital · 106d
Cleared Jul 05, 1985
VERSAPHAGE
K851272 · HQE
Alphamedix, Inc.
Ophthalmic · 95d
Cleared Jul 05, 1985
DASS PACK
K851280 · GIF
Dass, Inc.
Hematology · 95d
Cleared Jul 05, 1985
SDI PREPAX DILUKIT M.
K851320 · GIF
Scientific Distributors, Inc.
Hematology · 94d
Cleared Jul 05, 1985
CHESEBROUGH-POND'S SEQUENTIAL WOUND DRESSING
K851382 · NAD
Chesebrough-Pond'S U.S.A. Co.
General & Plastic Surgery · 88d