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
27241–27264 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 12, 2017
MESIRE - Balloon Sinus Dilatation System
K172737 · LRC
M/S. Meril Life Sciences Private Limited
Ear, Nose, Throat · 92d
Cleared Dec 12, 2017
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...
K173137 · LZA
Hartalega Sdn Bhd
General Hospital · 74d
Cleared Dec 12, 2017
Pure-Vu System
K173392 · FDF
Motus GI Medical Technologies , Ltd.
Gastroenterology & Urology · 43d
Cleared Dec 12, 2017
Advanced Diffusion Analysis (ADA) application
K173467 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 34d
Cleared Dec 12, 2017
T2Candida 1.1 Panel
K173536 · PII
T2biosystems, Inc.
Microbiology · 27d
Cleared Dec 11, 2017
Safety Blood Collection Device for Single Use
K170276 · FMI
Gemtier Medical (Shanghai), Inc.
General Hospital · 315d
Cleared Dec 11, 2017
SNIPER STAPLE SYSTEM, NON-STERILE
K172405 · JDR
Trilliant Surgical
Orthopedic · 124d
Cleared Dec 11, 2017
Crystalsert Lens Delivery System
K173480 · MSS
Bausch & Lomb, Inc.
Ophthalmic · 28d
Cleared Dec 11, 2017
CorticaLINK Spinal Fusion Platform
K173484 · NKB
Linkspine, Inc.
Orthopedic · 28d
Cleared Dec 11, 2017
Optima XR646 HD
K173612 · KPR
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 19d
Cleared Dec 10, 2017
Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G...
K172713 · PRI
Fujirebio Diagnostics,Inc.
Microbiology · 93d
Cleared Dec 10, 2017
Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)
K172722 · LSR
Euroimmun Us, Inc.
Microbiology · 90d
Cleared Dec 08, 2017
Cerebrotech CMS-5000
K171186 · QAF
Cerebrotech Medical Systems
Neurology · 228d
Cleared Dec 08, 2017
W&H Assistina Twin
K171553 · EFB
W&H Dentalwerk Buermoos GmbH
Dental · 192d
Cleared Dec 08, 2017
Clear Guide SCENERGY
K171677 · JAK
Clear Guide Medical
Radiology · 185d
Cleared Dec 08, 2017
Med-Hot Thermal Imaging Systems
K171928 · LHQ
Med-Hot Thermal Imaging, Inc.
Radiology · 164d
Cleared Dec 08, 2017
8ch Flex Suite
K172222 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 137d
Cleared Dec 08, 2017
InMode PLUS System
K172302 · PBX
Inmode MD , Ltd.
General & Plastic Surgery · 130d
Cleared Dec 08, 2017
RoyalGuard Surgical Gown, i600, Breathable
K172445 · FYA
Gri Medical & Electrical Technology...
General Hospital · 116d
Cleared Dec 08, 2017
LipiVage
K172714 · MUU
Genesis Biosystems, Inc.
General & Plastic Surgery · 91d
Cleared Dec 08, 2017
VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)
K172731 · LON
bioMerieux, Inc.
Microbiology · 88d
Cleared Dec 08, 2017
Varian cage
K172756 · MAX
Medyssey USA, Inc.
Orthopedic · 86d
Cleared Dec 08, 2017
MDS Plating System
K172786 · HRS
Miami Device Solutions, LLC
Orthopedic · 84d
Cleared Dec 08, 2017
CMS-2000 Central Monitoring System
K172966 · MHX
Advanced Instumentations, Inc.
Cardiovascular · 73d