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
145873–145896 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 1986
CARDIMAX FX-406U
K854505 · DRS
Brentwood Instruments, Inc.
Cardiovascular · 84d
Cleared Feb 04, 1986
STORZ DAISY
K854508 · HQE
Storz Instrument Co.
Ophthalmic · 84d
Cleared Feb 04, 1986
UROSTAT
K854539 · KPN
Urologics, Inc.
Gastroenterology & Urology · 83d
Cleared Feb 04, 1986
MONOJECT STERILE M200 ALUMINUM/M250 POLYPROPYLENE
K854547 · FMI
Sherwood Medical Co.
General Hospital · 83d
Cleared Feb 04, 1986
MONOJECT STERILE M216 BLOOD COLLECTION NEEDLES
K854548 · FMI
Sherwood Medical Co.
General Hospital · 83d
Cleared Feb 04, 1986
MONOJECT STERILE M400 PLASTIC&STERILE M401 ALUMINU
K854549 · FMI
Sherwood Medical Co.
General Hospital · 83d
Cleared Feb 04, 1986
STORZ MVS DISPOSABLE FIBEROPTIC LIGHTPIPE
K854587 · HBI
Storz Instrument Co.
General & Plastic Surgery · 78d
Cleared Feb 04, 1986
INSTA-GLAZE
K854588 · EJR
George Taub Products & Fusion Co., Inc.
Dental · 78d
Cleared Feb 04, 1986
NORFOLK MEDICAL PERITONEAL-ACCESS PORT
K854593 · LMQ
Norfolk Medical Products, Inc.
General Hospital · 78d
Cleared Feb 04, 1986
PATIENTMATE TM
K854754 · FPA
Trend Medical, Inc.
General Hospital · 69d
Cleared Feb 04, 1986
SUNGLASSES
K854818 · HQY
Jarnger Trading Co., Ltd.
Ophthalmic · 63d
Cleared Feb 04, 1986
EVEREST & JENNING SERIES 5000 MODULAR BED
K854832 · FNL
Carrom Healthcare, Inc.
General Hospital · 63d
Cleared Feb 04, 1986
CYTOMEGELISA M TEST KIT
K854839 · LKQ
Whittaker Bioproducts, Inc.
Microbiology · 62d
Cleared Feb 04, 1986
WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24
K854851 · GTJ
Wellcome Diagnostics
Microbiology · 61d
Cleared Feb 04, 1986
WELLCOGEN BACTERIAL ANTIGEN KIT
K854852 · GTJ
Wellcome Diagnostics
Microbiology · 61d
Cleared Feb 04, 1986
SYSTEMS OF SIGHT LOW VISION EYEWARE
K854854 · HOI
Int'L Eye Care, Inc.
Ophthalmic · 61d
Cleared Feb 04, 1986
EVEREST & JENNINGS TRADITION-STANDARD BED L109684&
K854867 · FNL
Carrom Healthcare, Inc.
General Hospital · 61d
Cleared Feb 04, 1986
INTRAOCULAR PRESSURE REDUCER
K854873 · LCR
Mira, Inc.
Toxicology · 62d
Cleared Feb 04, 1986
SUNGLASSES
K854879 · HQY
Jarnger Trading Co., Ltd.
Ophthalmic · 60d
Cleared Feb 04, 1986
CARROM CARELIFE SERIES 40000 MODULAR BES SYSTEM
K854937 · FNL
Carrom Healthcare, Inc.
General Hospital · 56d
Cleared Feb 04, 1986
MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS
K854949 · HQF
CooperVision, Inc.
Ophthalmic · 56d
Cleared Feb 04, 1986
OPTRONICS CONTRAST ACUITY TESTER
K854983 · HOX
Optronics, Inc.
Ophthalmic · 54d
Cleared Feb 04, 1986
BARTELL SMALL INCISION LENS GLIDE
K854994 · KYB
Microtech, Inc.
Ophthalmic · 54d
Cleared Feb 04, 1986
DURAHESIVE WAFER WITH FLANGE
K855018 · EXB
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 50d