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
138889–138912 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 1987
MITRAFLEX(TM) WOUND DRESSING
K873277 · NAD
Matrix Medica, Inc.
General & Plastic Surgery · 31d
Cleared Sep 16, 1987
WAKO(TM) ZN TEST
K863920
Wako Chemicals USA, Inc.
Chemistry · 343d
Cleared Sep 16, 1987
CENTRAL VENOUS MULTI-LUMEN CATHETERS AND KITS
K871573 · DQY
Spectramed, Inc.
Cardiovascular · 147d
Cleared Sep 16, 1987
GLUCOCHEK S.C. WITH AUDIO OPTION
K871586 · CGA
Larken Industries, Inc.
Chemistry · 146d
Cleared Sep 16, 1987
NASOGASTRIC VOICETUBE
K871632 · BTR
American Omni Medical, Inc.
Anesthesiology · 142d
Cleared Sep 16, 1987
COULTER DART CK-MB ISOENZYME REAGENT SYSTEM
K872041 · JHT
Coulter Electronics, Inc.
Chemistry · 112d
Cleared Sep 16, 1987
RVT-50 ROTARY CHAIR FOR VESTIBULAR TESTING
K872093 · LXV
Ics Medical Corp.
Ear, Nose, Throat · 107d
Cleared Sep 16, 1987
SURGITEK INFUSION STENT SYSTEM*
K872353 · FAD
Surgitek
Gastroenterology & Urology · 90d
Cleared Sep 16, 1987
LARKEL DEVICE W/ATTACHMENTS A-H
K872486 · BTO
Seidel Medizin GmbH
Anesthesiology · 85d
Cleared Sep 16, 1987
HEWSON A.C.L. GUIDE SET
K872608 · KGS
Concept, Inc.
General & Plastic Surgery · 72d
Cleared Sep 16, 1987
MASTER-FIT HEARING EVALUA. & RECOM. (HEAR) SYSTEM
K872633 · ETW
Hearing Health Care Program
Ear, Nose, Throat · 72d
Cleared Sep 16, 1987
SPECTROPHOTOMETERS MODELS:ABC+,ABC,S 500, S 1000
K872749 · JJQ
Secomam Co.
Chemistry · 65d
Cleared Sep 16, 1987
LACTATE DEHYDROGENASE ISOENZYME 1
K872891 · CEX
Data Medical Associates, Inc.
Chemistry · 55d
Cleared Sep 16, 1987
IN THE EAR HEARING AID
K872922 · ESD
Audio Hearing Aid Service
Ear, Nose, Throat · 51d
Cleared Sep 16, 1987
AMERICAN BRAIN RETRACTOR COVER
K872951 · GET
American Silk Sutures, Inc.
General & Plastic Surgery · 50d
Cleared Sep 16, 1987
HEARING AID (ALL-IN-THE-EAR)
K872977 · ESD
The Hour Glass
Ear, Nose, Throat · 48d
Cleared Sep 16, 1987
TRANSIGEN EXUDATE CONTROLLED WOUND DRESSING
K872988 · NAD
Smith & Nephew, Inc.
General & Plastic Surgery · 47d
Cleared Sep 16, 1987
HEARING AID (ALL IN THE EAR)
K872995 · ESD
Sound Crafters Hearing Instruments
Ear, Nose, Throat · 47d
Cleared Sep 16, 1987
CONCEPT ARTHROSCOPIC PORTAL ROD
K873030 · HRX
Concept, Inc.
Orthopedic · 43d
Cleared Sep 16, 1987
PRECISION HIP LONG STEM FEMORAL COMPONENT SYSTEM
K873089 · JDG
Howmedica Corp.
Orthopedic · 42d
Cleared Sep 16, 1987
REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROL
K873105 · JJX
Streck Laboratories, Inc.
Chemistry · 40d
Cleared Sep 16, 1987
UNIFAST CK-MB
K873134 · CGS
Sclavo, Inc.
Chemistry · 37d
Cleared Sep 16, 1987
VARUS AND VALGUS LEG HOLDER
K873139 · FWZ
Leonard Medical, Inc.
General & Plastic Surgery · 37d
Cleared Sep 16, 1987
CAULK'S VPS CARTRIDGE SYSTEM
K873153 · EID
Dentsply Intl.
Dental · 36d