FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
150049–150072 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 04, 1985
LEUKOSTIX REAGENT STRIPS FOR URINALYSIS
K843727 · LJX
Miles Laboratories, Inc.
Chemistry · 102d
Cleared Jan 04, 1985
LATEX-R RICKETTSII
K843794 · GPP
Health Research, Inc.
Microbiology · 99d
Cleared Jan 04, 1985
CLEANSE N BOND I
K844133 · DYH
Lee Pharmaceuticals
Dental · 73d
Cleared Jan 04, 1985
CLEANSE N BOND II
K844134 · DYH
Lee Pharmaceuticals
Dental · 73d
Cleared Jan 04, 1985
ACTIVE VERTICAL CORRECTOR APPLIANCE
K844234 · ECO
Active Vertical Correctors, Inc.
Dental · 64d
Cleared Jan 04, 1985
BBL PORT-A-CUL 21628 DOUBLE SWAB SULTURE COLLECTIO
K844369 · JSM
Precision Dynamics Corp.
Microbiology · 52d
Cleared Jan 04, 1985
BBL PORT-A-CUL 21627 SINGLE SWAB CULTURE COLLECT
K844370 · JSM
Precision Dynamics Corp.
Microbiology · 52d
Cleared Jan 04, 1985
BILE DIFFERENTIAL DISK
K844380 · JTO
Anaerobe Systems
Microbiology · 52d
Cleared Jan 04, 1985
COLISTIN 10 MCG. DIFFERENTIAL DISK
K844381 · JTO
Anaerobe Systems
Microbiology · 52d
Cleared Jan 04, 1985
VANCOMYCIN 5MCG DIFFERENTIAL DISK
K844382 · JTO
Anaerobe Systems
Microbiology · 52d
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