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
150649–150672 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 04, 1985
KANAMYCIN 1000 MCG DIFFERENTIAL DISK
K844383 · JTO
Anaerobe Systems
Microbiology · 52d
Cleared Jan 04, 1985
SIGMA PEROXIDASE MYELOPEROXIDASE STAINING PROCEDUR
K844402 · GIA
Sigma Chemical Co.
Pathology · 52d
Cleared Jan 04, 1985
BEHIND THE EAR HEARING AIDS BERNAFON X-13
K844425 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 50d
Cleared Jan 04, 1985
SIMPLIFLOS DENTAL FLOSSER
K844438 · JES
Valiant Steel & Equipment, Inc.
Dental · 49d
Cleared Jan 04, 1985
HAND-HELD SLIDE READER
K844473 · LIB
Portable Medical Laboratories, Inc.
Microbiology · 46d
Cleared Jan 04, 1985
MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL
K844678 · DHN
Meloy Laboratories, Inc.
Immunology · 35d
Cleared Jan 04, 1985
VIRAL TRANSPORT MEDIA
K844747 · JSM
Hillcrest Biologicals
Microbiology · 29d
Cleared Jan 04, 1985
SUNGLASSES
K844778 · HQG
B & M Sporting Goods, Inc.
Ophthalmic · 25d
Cleared Jan 03, 1985
COPAL DIGITAL THERMOMETER UF-10
K843040 · FLL
Takeda Medical, Inc.
General Hospital · 154d
Cleared Jan 03, 1985
OLYMPUS CHP-P10 NEPHROSCOPE/CYSTOSCOPE
K843084 · FBO
Olympus Corp.
Gastroenterology & Urology · 150d
Cleared Jan 03, 1985
URINARY DRAINAGE CONTAINER 2012-WITH
K843441 · FFG
Vital Metrics, Inc.
Gastroenterology & Urology · 121d
Cleared Jan 03, 1985
URINARY DRAINAGE CONTAINER 2013 WITH
K843442 · FFG
Vital Metrics, Inc.
Gastroenterology & Urology · 121d
Cleared Jan 03, 1985
STEINWAY MICRO-KERATO-TREPHINE
K843646 · HRH
Steinway Instrument Co., Inc.
Ophthalmic · 108d
Cleared Jan 03, 1985
APPARATUS & METHODS SELF-EXAM OF EYE
K843702 · HOQ
Wheel Checkers
Ophthalmic · 104d
Cleared Jan 03, 1985
ANTI-ASPIRATION VALVE
K843748 · FPA
Travenol Laboratories, S.A.
General Hospital · 100d
Cleared Jan 03, 1985
AUTOLOADER II
K843779 · JQW
Electro-Nucleonics Laboratories, Inc.
Chemistry · 100d
Cleared Jan 03, 1985
STAT/PB REAGENT
K843839 · DOF
Tri-Tech, Inc.
Chemistry · 94d
Cleared Jan 03, 1985
FLUOROSCOPIC AUTOMATIC BRIGHTNESS CNTL
K843917 · JAA
Afp Imaging Corp.
Radiology · 90d
Cleared Jan 03, 1985
ANGIOPLUS-S
K843972 · JAA
Oec-Diasonics, Inc.
Radiology · 84d
Cleared Jan 03, 1985
HOBBS MEDICAL POLYPECTOMY SNARE
K844074 · OCZ
Hobbs Medical, Inc.
Gastroenterology & Urology · 76d
Cleared Jan 03, 1985
MODIFIED C-DAK
K844185 · KOC
Cd Medical, Inc.
Gastroenterology & Urology · 66d
Cleared Jan 03, 1985
CALCIUM REAGENT FOR DEMAND ANALYZER
K844241 · CIC
Advanced Biomedical Methods, Inc.
Chemistry · 63d
Cleared Jan 03, 1985
CHOLESTEROL REAGENT FOR DEMAND ANALYZER
K844242 · CHH
Advanced Biomedical Methods, Inc.
Chemistry · 63d
Cleared Jan 03, 1985
TOTAL BILIRUBIN FOR DEMAND ANALYZER
K844243 · CIC
Advanced Biomedical Methods, Inc.
Chemistry · 63d