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
79825–79848 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 25, 2001
AMBU GEL, HYDROGEL BURN DRESSING
K010583 · MGQ
Ambu, Inc.
General & Plastic Surgery · 87d
Cleared May 25, 2001
GOODNET
K010763 · LLZ
Goodman Co., Ltd.
Radiology · 72d
Cleared May 25, 2001
SNOW LOTUS POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT...
K010947 · LYY
Beijing Reagent Latex Products Co., Ltd.
General Hospital · 57d
Cleared May 25, 2001
POWDER-FREE STERILE SYNTHETIC VINYL EXAMINATION GLOVES
K011186 · LYZ
Allegiance Healthcare Corp.
General Hospital · 37d
Cleared May 25, 2001
RADIUS COUGAR WIRE
K011287 · DQX
Radius Medical Technologies, Inc.
Cardiovascular · 28d
Cleared May 25, 2001
EVERGREEN AND MULTIPLE PRIVATE LABELS NON-STERILE POWDERED LATEX PATIENT...
K011376 · LYY
Yty Industry (Manjung) Sdn Bhd
General Hospital · 21d
Cleared May 25, 2001
HUMMER IV MICRODEBRIDER SYSTEM
K011381 · ERL
Stryker Instruments
Ear, Nose, Throat · 18d
Cleared May 24, 2001
HEMODIALYSIS TUBING SETS
K001971 · FIB
Ofi Biomedica S.P.A.
Gastroenterology & Urology · 330d
Cleared May 24, 2001
SPO2 WRAP SENSOR
K002848 · DQA
Epic Medical Equipment Services, Inc.
Anesthesiology · 253d
Cleared May 24, 2001
BIOSLING - BIOABSORBABLE POLYMER SLING & SURGICAL MESH
K010533 · FTL
Injectx, Inc.
General & Plastic Surgery · 90d
Cleared May 24, 2001
INFANT LIMB HOLDER, MODELS 306080 & 306081
K010818 · FMQ
Skil-Care Corp.
General Hospital · 66d
Cleared May 24, 2001
VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION
K010858 · MYI
Id Biomedical Corp.
Microbiology · 63d
Cleared May 24, 2001
NEEDLELOK HYPODERMIC NEEDLE PROTECTION
K011004 · FMI
Diasol, Inc.
General Hospital · 50d
Cleared May 24, 2001
ALPCO MILENIA ANTI-TPO ELISA
K011201 · JZO
American Laboratory Products Co., Ltd.
Immunology · 35d
Cleared May 24, 2001
TC-PLUS POROUS FEMORAL COMPONENTS
K011258 · JWH
Plus Orthopedics
Orthopedic · 30d
Cleared May 24, 2001
TC-PLUS POROUS TIBIAL COMPONENTS
K011288 · JWH
Plus Orthopedics
Orthopedic · 27d
Cleared May 24, 2001
ULTRAGUIDE MR-GUIDE 3000
K011418 · LNH
Ultraguide , Ltd.
Radiology · 15d
Cleared May 24, 2001
VIVA
K011480 · HIS
Richter Rubber Technology Sdn. Bhd.
Obstetrics & Gynecology · 10d
Cleared May 23, 2001
VEGA ULTRASONIC NEBULIZER
K002831 · CAF
Vega Technologies, Inc.
Anesthesiology · 254d
Cleared May 23, 2001
BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690
K003251 · BSZ
Blease Medical Equipment , Ltd.
Anesthesiology · 218d
Cleared May 23, 2001
WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL...
K003618 · NDD
Whiteside Biomechanics, Inc.
Orthopedic · 182d
Cleared May 23, 2001
POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND...
K004049 · LPL
Optech, Inc.
Ophthalmic · 145d
Cleared May 23, 2001
SYNTHES ANTEROLATERAL CALCANEAL PLATE
K010518 · KTT
Synthes (Usa)
Orthopedic · 90d
Cleared May 23, 2001
ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM
K010525 · HWC
Arthrex, Inc.
Orthopedic · 90d