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
165049–165072 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 1981
NIKKISO ND-14 PARALLEL FLOW DIALYZER
K803068 · FJG
NIKKISO CO., LTD.
Gastroenterology & Urology · 90d
Cleared Mar 04, 1981
PROCEDURE & RECOVERY PATIENT SUIT
K803171 · FYB
Alba Health Care
General Hospital · 79d
Cleared Mar 04, 1981
EYETECH-VISION SCREENING SYSTEM
K803256 · HOX
Eyedex
Ophthalmic · 71d
Cleared Mar 04, 1981
STEREO AUDITORY TRAINER (MODEL PM228)
K810031 · EPF
Hc Electronics
Ear, Nose, Throat · 57d
Cleared Mar 04, 1981
ACCUFLO 100
K810074 · KOC
Renal Care Corp.
Gastroenterology & Urology · 50d
Cleared Mar 04, 1981
PORCELAIN POWDER FOR CLINICAL USE
K810096 · EIH
Dentsply Intl.
Dental · 49d
Cleared Mar 04, 1981
TAMPAX DEODORANT TAMPONS
K810143 · HIL
Tampax, Inc.
Obstetrics & Gynecology · 42d
Cleared Mar 04, 1981
NEBULIZER HEATER
K810217 · CAF
Corpak Co.
Anesthesiology · 36d
Cleared Mar 04, 1981
PREFILLED NEBULIZER
K810218 · CAF
Corpak Co.
Anesthesiology · 36d
Cleared Mar 04, 1981
PREFILLED HUMIDIFER
K810219 · BTT
Corpak Co.
Anesthesiology · 36d
Cleared Mar 04, 1981
IMPLANTABLE PACEMAKER LEAD ADAPTER
K810245 · DTD
Intermedics, Inc.
Cardiovascular · 34d
Cleared Mar 04, 1981
DAVOL ELECTRO MEDICAL SYSTEMS
K810273 · GEI
C.R. Bard, Inc.
General & Plastic Surgery · 30d
Cleared Mar 04, 1981
MODULUS VERNI-TROL ANESTHETIC VAPORIZER
K810289 · CAD
Ohio Medical Products
Anesthesiology · 30d
Cleared Mar 04, 1981
CAM-WRAP
K810292 · FTA
Medline Industries, Inc.
Radiology · 29d
Cleared Mar 04, 1981
ELECATH DUAL MODE TRANSTHORACIC PACING
K810312 · LDF
Electro-Catheter Corp.
Cardiovascular · 27d
Cleared Mar 04, 1981
HEATPAC
K810320 · IMB
Shinsei Corp.
Physical Medicine · 26d
Cleared Mar 04, 1981
REINFORCED TRACHEOSTOMY TUBE SET(TENTAT)
K810321 · BTO
National Catheter Co. Div. Mallinckrodt
Anesthesiology · 26d
Cleared Mar 04, 1981
EARETTE HEARING AID SEARS #8054
K810379 · FSD
Oticon Corp.
General Hospital · 19d
Cleared Mar 04, 1981
EARETTE HEARING AID SEARS MODEL 8053
K810389 · ESD
Oticon Corp.
Ear, Nose, Throat · 15d
Cleared Mar 04, 1981
VOGLER HYSTERECTOMY FORCEPS (SMALL & LG)
K810391 · HCZ
Edward Weck, Inc.
Obstetrics & Gynecology · 15d
Cleared Mar 04, 1981
ACE COLD BANDAGE
K810402 · IME
Bd Becton Dickinson Vacutainer...
Physical Medicine · 14d
Cleared Mar 04, 1981
TRACHEOSTOMA VENT
K810436 · BTO
Bivona Medical Technologies
Anesthesiology · 13d
Cleared Mar 04, 1981
BODY STRAP
K810439 · KNO
Fred Sammons, Inc.
Physical Medicine · 13d
Cleared Mar 04, 1981
HAND SPLINTS AND COMPONENTS
K810442 · ILH
Fred Sammons, Inc.
Physical Medicine · 13d