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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
105217–105240 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 1994
MERIT (O.1T MR SYSTEM)
K943415 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 153d
Cleared Dec 15, 1994
GIP/MEDI-GLOBE GOREIGN BODY GRASPERS
K943476 · OCZ
Medi-Globe Corp.
Gastroenterology & Urology · 149d
Cleared Dec 15, 1994
STRYKER TOTAL PERFORMANCE SYSTEM
K943589 · HWE
Stryker Corp.
Orthopedic · 146d
Cleared Dec 15, 1994
DENTAL HYGIENE TRAY
K944139 · LYY
Sterile Concepts, Inc.
General Hospital · 113d
Cleared Dec 15, 1994
VERRUCA-FREEZE(TM) CRYOSURGICAL DELIVERY SYST, MODIFIED
K944221 · GEH
Cryosurgery, Inc.
General & Plastic Surgery · 122d
Cleared Dec 15, 1994
ADVANCE CORP. SUNGLASSES
K944235 · HQY
Advance Corp.
Ophthalmic · 106d
Cleared Dec 15, 1994
KARL STORZ INSULATED SCISSORS
K944297 · KNF
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 100d
Cleared Dec 15, 1994
KARL STORZ INSULATED BIOPSY FORCEPS
K944300 · KNF
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 100d
Cleared Dec 15, 1994
BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEM
K944319 · KZK
Giles Scientific, Inc.
Microbiology · 104d
Cleared Dec 15, 1994
SUNGLASSES
K944398 · HQY
Sun Island Enterprise Co., Ltd.
Ophthalmic · 97d
Cleared Dec 15, 1994
E.COLI 0157 LATEX TEST
K944421 · GMZ
Pro-Lab Diagnostics
Microbiology · 119d
Cleared Dec 15, 1994
OPTILITE V FIBEROPTIC ACCESSORIES
K944474 · GEX
Xintec Corporation
General & Plastic Surgery · 97d
Cleared Dec 15, 1994
HUMPHREY OCT (OPTICAL COHERENCE TOMOGRAPHY) SCANNER
K944523 · IYO
Humphrey, Inc.
Radiology · 90d
Cleared Dec 15, 1994
AQUAFRESH PLAQUE FIGHTING GUM
K944575 · EJR
Smithkline Beecham Consumer...
Dental · 87d
Cleared Dec 15, 1994
CONMED VERSA STEM NEUROMUSCULAR STIMULATION/TENS
K944603 · GXY
Conmedcorp
Neurology · 87d
Cleared Dec 15, 1994
ORTHOLOC ADVANTIM MODULAR FEMORAL AUGMENT COMPONENT
K944845 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 76d
Cleared Dec 15, 1994
GOGGLE SAFEGUARD
K944857 · HOY
Sellstrom Mfg. Co.
Ophthalmic · 76d
Cleared Dec 15, 1994
HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT
K944876 · DAS
Research Diagnostics, Inc.
Immunology · 73d
Cleared Dec 15, 1994
BODILY FLUID DISPOSAL KIT
K944880 · FXX
Clinical Resources, Inc.
General Hospital · 73d
Cleared Dec 15, 1994
PULPDENT HARDSHELL
K945173 · EBF
Pulpdent Corp.
Dental · 55d
Cleared Dec 15, 1994
SPECTACLE FRAME OR EYEGLASS FRAMES
K945176 · HQZ
Optipia Trading Co.
Ophthalmic · 52d
Cleared Dec 15, 1994
MAVIG LOWER BODY PROTECTION SYSTEMS, ASSEMBLY MODELS 6265, 6266, 6267, 6268,...
K945238 · IWQ
F. Walter Hanel GmbH
Radiology · 49d
Cleared Dec 15, 1994
SPECTACLE FRAME
K945392 · HQZ
Seo Han Corp., Ltd.
Ophthalmic · 42d
Cleared Dec 15, 1994
CONVERTIBLE CONTACT SIDE-FIRING REFRACTIVE FIBER (C-SRF(TM))
K945563 · GEX
Energy Life Systems Corp.
General & Plastic Surgery · 38d