FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

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

Filters: Cleared only ×
175,230 results
4873–4896 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 2025
BTL-754
K241270 · GEX
BTL Industries, Inc.
General & Plastic Surgery · 269d
Cleared Jan 30, 2025
Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)
K233956 · DQA
Taiwan Aulisa Medical Devices...
Anesthesiology · 412d
Cleared Jan 29, 2025
Versalock Upper Limb Plating System
K243740 · HRS
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 56d
Cleared Jan 29, 2025
Xenco Medical CancelleX Cervical Interbody System
K243673 · ODP
Xenco Medical, LLC
Orthopedic · 63d
Cleared Jan 29, 2025
GYDER® Hip System
K243387 · OLO
Gyder Surgical Pty, Ltd.
Orthopedic · 90d
Cleared Jan 29, 2025
Self-Forming Magnet (FLEX SFM)
K243213 · SAH
GI Windows, Inc.
General & Plastic Surgery · 118d
Cleared Jan 29, 2025
Digital Video Processor
K243117 · FGB
Hunan Vathin Medical Instrument Co.,...
Gastroenterology & Urology · 121d
Cleared Jan 29, 2025
Co-Ablation System with Sterile Co-Ablation Probe
K243042 · GEH
Hygea Medical Technology Co., Ltd.
General & Plastic Surgery · 124d
Cleared Jan 29, 2025
Surcam Dental Implant System
K242217 · DZE
Surcam Medical Devices and...
Dental · 184d
Cleared Jan 29, 2025
CareSuperb™ COVID-19 Antigen Home Test
K241915 · QYT
Access Bio, Inc.
Microbiology · 212d
Cleared Jan 28, 2025
SANSA HSAT
K244027 · MNR
Huxley Medical
Anesthesiology · 29d
Cleared Jan 28, 2025
Argo Knotless GENESYS Anchor
K244025 · MBI
Conmed Corporation
Orthopedic · 32d
Cleared Jan 28, 2025
Alignment System Cranial, with Alignment Software Cranial with LITT
K243698 · HAW
Brainlab AG
Neurology · 60d
Cleared Jan 28, 2025
3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE
K243501 · FRC
3M Company
General Hospital · 77d
Cleared Jan 28, 2025
Medical Monitor (27HS714S)
K243439 · GCJ
Lg Electronics.Inc
General & Plastic Surgery · 83d
Cleared Jan 28, 2025
LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB,...
K243423 · OHS
Shenzhen Rainbow Technology Co., Ltd.
General & Plastic Surgery · 85d
Cleared Jan 28, 2025
HemosIL CL HIT-IgG(PF4-H)
K243374 · LCO
Instrumentation Laboratory (IL) Co.
Hematology · 90d
Cleared Jan 27, 2025
Symani Surgical System (820-03830)
K250014 · SAQ
Medical Microinstruments, Inc.
General & Plastic Surgery · 25d
Cleared Jan 27, 2025
Bunkerhill AVC
K243229 · JAK
BunkerHill Health
Radiology · 111d
Cleared Jan 27, 2025
CO2 Laser Therapy Systems (SHE-LSP003-1)
K242941 · GEX
Beijing Sano Laser S&T Development...
General & Plastic Surgery · 124d
Cleared Jan 27, 2025
Imaging system of positron emission and X-ray computed tomography (DigitMI 930)
K241266 · KPS
Raysolution Healthcare Co., Ltd.
Radiology · 266d
Cleared Jan 27, 2025
Firstar Dental Unit
K231297 · EIA
Firstar Dental Company
Dental · 634d
Cleared Jan 24, 2025
MAGENTIQ-COLO (ME-APDS)
K244023 · QNP
Magentiq Eye, Ltd.
Gastroenterology & Urology · 28d
Cleared Jan 24, 2025
AxCess® Expandable Interbody System
K243739 · MAX
Elliquence, LLC
Orthopedic · 51d