FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
111529–111552 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 06, 1994
OPHTHALMIC TRIAL LENSES
K930195 · HPC
Optimark Accessories and Instruments
Ophthalmic · 357d
Cleared Jan 06, 1994
ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD.
K930790 · BZQ
Bio-Logic Systems Corp.
Anesthesiology · 324d
Cleared Jan 06, 1994
SILON SILICONE GEL SHEET
K932214 · MDA
Bio Med Sciences, Inc.
General & Plastic Surgery · 244d
Cleared Jan 06, 1994
VISUAL SCENE SUNGLASSES
K932469 · HQY
Vsi Intl., Inc.
Ophthalmic · 230d
Cleared Jan 06, 1994
PRECISION INTRA-ORAL SCOPES
K932878 · EIA
Precise Optics
Dental · 206d
Cleared Jan 06, 1994
CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL
K933199 · EMA
Confi-Dental Products Co.
Dental · 266d
Cleared Jan 06, 1994
CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIF
K933235 · DWZ
Cordis Corp.
Cardiovascular · 232d
Cleared Jan 06, 1994
PRO-PHACO HANDPIECE
K933503 · HQC
M. Imonti and Associates Inc.,
Ophthalmic · 171d
Cleared Jan 06, 1994
10MM DISPOSABLE, STERILE SUCTION CANNULA
K933789 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 155d
Cleared Jan 06, 1994
5MM DISPOSABLE SUCTION-IRRIGATION CANNULA
K933790 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 155d
Cleared Jan 06, 1994
FINE OPTICS SUNGLASSES
K933938 · HQY
Fine Optics, Inc.
Ophthalmic · 147d
Cleared Jan 06, 1994
SUNGLASSES
K934020 · HQY
Sun Probe Enterprise Co., Ltd.
Ophthalmic · 142d
Cleared Jan 06, 1994
3M CURING LIGHT XL1500
K934746 · EBZ
3M Company
Dental · 94d
Cleared Jan 06, 1994
CPROTECTOR
K934821 · CBP
Certified Safety Mfg., Inc.
Anesthesiology · 90d
Cleared Jan 06, 1994
EMIT(R) IIC OPIATE ASSAY
K935117 · DJG
Syva Co.
Toxicology · 71d
Cleared Jan 06, 1994
BIKER MICE SUNGLASSES
K935165 · HQY
Ja-Ru, Inc.
Ophthalmic · 69d
Cleared Jan 06, 1994
PONTOR LFC
K935387 · EJT
Metalor
Dental · 58d
Cleared Jan 06, 1994
CERAPALL 4CF
K935388 · EJS
Metalor
Dental · 58d
Cleared Jan 06, 1994
GC ELITE CEMENT
K935521 · EMA
GC America, Inc.
Dental · 49d
Cleared Jan 06, 1994
SUNGLASSES
K935541 · HQY
Seven Pyramid Ent Co., Ltd.
Ophthalmic · 51d
Cleared Jan 05, 1994
ELS AUTOMATIC TUBING CLAMP SYSTEM
K921993 · FIG
Rocky Mountain Research, Inc.
Gastroenterology & Urology · 617d
Cleared Jan 05, 1994
MODEL MEDILOG RAPIDE
K923737 · BZQ
Oxford Medilog, Inc.
Anesthesiology · 527d
Cleared Jan 05, 1994
KINETIK GREAT TOE SYSTEM
K924724 · LZJ
Kinetikos Medical, Inc.
Orthopedic · 471d
Cleared Jan 05, 1994
PRISM BONE CEMENT MIXING SYSTEM
K925025 · JDZ
Depuy, Inc.
Orthopedic · 460d