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
4585–4608 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 31, 2025
Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel...
K241334 · LDF
C.R. Bard, Inc.
Cardiovascular · 266d
Cleared Jan 31, 2025
AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)
K241193 · JFB
Marzzan Lucas Jorge
Physical Medicine · 277d
Cleared Jan 30, 2025
Osprey Suture Anchor
K243726 · MBI
Responsive Arthroscopy, Inc.
Orthopedic · 58d
Cleared Jan 30, 2025
WasherCap™ Mini Fixation System (Model 45)
K243712 · MBI
Abanza Tecnomed S.L
Orthopedic · 59d
Cleared Jan 30, 2025
iBOT® PMD
K243442 · IMK
Mobius Mobility
Physical Medicine · 85d
Cleared Jan 30, 2025
simpli-COLLECT STI Test
K243410 · QYA
Abbott Molecular
Microbiology · 90d
Cleared Jan 30, 2025
MTS Ceftobiprole 0.002-32 µg/mL
K243202 · JWY
Liofilchem S. R. L.
Microbiology · 121d
Cleared Jan 30, 2025
TeleRPM Gen2 Blood Glucose Monitoring System
K243060 · NBW
Guangdong Transtek Medical...
Chemistry · 125d
Cleared Jan 30, 2025
Ureteral Access Sheath
K243025 · FED
Seplou (Zhuhai) Co., Ltd.
Gastroenterology & Urology · 125d
Cleared Jan 30, 2025
Rotarex Atherectomy System
K242757 · MCW
Bard Peripheral Vascular, Inc.
Cardiovascular · 140d
Cleared Jan 30, 2025
Laboratorios Biogalenic Sterile Water for Inhalation, USP
K242717 · BTT
Laboratorios Biogalenic S.A. DE C.V.
Anesthesiology · 142d
Cleared Jan 30, 2025
Wrist Blood Pressure Monitor (OHMS11, OHMS12)
K242568 · DXN
Shenzhen Zhongkemingwang...
Cardiovascular · 154d
Cleared Jan 30, 2025
MyShoulder Planner (5.3SSWPL)
K241292 · KWS
Medacta International S.A.
Orthopedic · 267d
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