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
48793–48816 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 2010
POWDERED VINYL PATIENT EXAMINIATION GLOVES, CLEAR (NON-COLORED)
K102976 · LYZ
Heze Juxinyuan Food Co., Ltd.
General Hospital · 68d
Cleared Dec 13, 2010
EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM
K103419 · KWS
Exactech, Inc.
Orthopedic · 21d
Cleared Dec 13, 2010
VASCUTRAK PTA DILATATION CATHETER
K103459 · PNO
C.R. Bard, Inc.
Cardiovascular · 19d
Cleared Dec 10, 2010
PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000
K093298 · HKX
Keeler Instruments, Inc.
Ophthalmic · 415d
Cleared Dec 10, 2010
PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD
K100261 · FRO
Tei Biosciences, Inc.
General & Plastic Surgery · 316d
Cleared Dec 10, 2010
ABL837 FLEX ANALYZER
K100777 · CHL
Radiometer Medical Aps
Chemistry · 267d
Cleared Dec 10, 2010
LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM -...
K100858 · KWT
Lima-Lto S.P.A.
Orthopedic · 259d
Cleared Dec 10, 2010
RAPIDVIT BLAST, RAPIDWARM BLAST
K101003 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 242d
Cleared Dec 10, 2010
DEPUY ATTUNE KNEE SYSTEM
K101433 · OIY
DePuy Orthopaedics, Inc.
Orthopedic · 203d
Cleared Dec 10, 2010
ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH
K101520 · GEI
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 191d
Cleared Dec 10, 2010
ELECTRO INTERSTITIAL SCAN
K102166 · GZO
Ld Technology, LLC
Neurology · 130d
Cleared Dec 10, 2010
RII INFRARED EAR THERMOMETER,
K102187 · FLL
Radiant Innovation, Inc.
General Hospital · 129d
Cleared Dec 10, 2010
PIXI PEDIATRIC MASK
K102224 · BZD
Resmed, Ltd.
Anesthesiology · 126d
Cleared Dec 10, 2010
APEX SPINE SYSTEM W/ COCR RODS
K102488 · MNH
Spinecraft, LLC
Orthopedic · 101d
Cleared Dec 10, 2010
APTUS 1.5 TRILOCK
K102537 · HRS
Medartis AG
Orthopedic · 98d
Cleared Dec 10, 2010
VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED
K102618 · BTT
Draeger Medical AG & Co. KG
Anesthesiology · 88d
Cleared Dec 10, 2010
WILLOW/ELM PTA BALLOON DILATATION CATHETER
K102645 · LIT
Creagh Medical, Ltd.
Cardiovascular · 88d
Cleared Dec 10, 2010
MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID...
K102658 · CAF
Thayer Medical Corp.
Anesthesiology · 86d
Cleared Dec 10, 2010
QUANTA CYBER TM 150W
K102749 · GEX
Quanta System Spa
General & Plastic Surgery · 78d
Cleared Dec 10, 2010
INZONE DETACHMENT SYSTEM
K103008 · HCG
Boston Scientific Corp
Neurology · 59d
Cleared Dec 10, 2010
GENESYS SPINE INTERBODY FUSION SYSTEM
K103034 · MAX
Genesys Spine
Orthopedic · 58d
Cleared Dec 10, 2010
VASCUCOMP
K103247 · JOW
Thermotek, Inc.
Cardiovascular · 37d
Cleared Dec 10, 2010
U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS
K103311 · HEB
Kimberly Clark Corporation
Obstetrics & Gynecology · 30d
Cleared Dec 10, 2010
INFUSION SETS
K103344 · FPA
Hospira, Inc.
General Hospital · 25d