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: 2026–2026 ×
1,922 results
817–840 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared May 07, 2026
Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue
K260460 · NHA
Institut Straumann AG
Dental · 85d
Cleared May 07, 2026
Lynx Aspiration Catheter System
K254276 · NRY
Q'Apel Medical, Inc.
Neurology · 128d
Cleared May 07, 2026
MR Conditional Cup Electrodes
K254183 · GXY
Technomed Europe
Neurology · 135d
Cleared May 07, 2026
Veritas Reverse Total Shoulder System
K253992 · PHX
Restor3d
Orthopedic · 146d
Cleared May 07, 2026
SPECTRALIS HRA+OCT and variants
K253837 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 157d
Cleared May 07, 2026
Aliya® EX System
K253826 · OAB
Galvanize Therapeutics, Inc.
General & Plastic Surgery · 157d
Cleared May 07, 2026
SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System,...
K253739 · NKB
Globus Medical, Inc.
Orthopedic · 164d
Cleared May 07, 2026
Evita (V800)
K253647 · CBK
Draegerwerk AG & CO Kgaa
Anesthesiology · 168d
Cleared May 06, 2026
CastleLoc-P Anterior Cervical Plate System
K261112 · KWQ
L & K Biomed Co., Ltd.
Orthopedic · 33d
Cleared May 06, 2026
Polyethylene
K260775 · GAT
Teleflex Medical, LLC
General & Plastic Surgery · 57d
Cleared May 06, 2026
YP-710T Series NIBP Cuff
K260747 · DXQ
Nihon Kohden Corporation
Cardiovascular · 61d
Cleared May 06, 2026
Denture Base
K260376 · EBI
Shandong Huge Dental Material...
Dental · 90d
Cleared May 06, 2026
KardiaPSI Balloon Catheter
K253855 · OZT
Intervention Tech, Inc. ; dba Corvention
Cardiovascular · 154d
Cleared May 06, 2026
BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)
K253152 · DXN
Biozen, LLC
Cardiovascular · 222d
Cleared May 06, 2026
Anchor with Fiber Wire and Disposable Inserter
K253027 · MBI
Ortobio S.A.
Orthopedic · 229d
Cleared May 06, 2026
Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)
K252552 · KPI
Shenzhen Changkun Technology Co., Ltd.
Gastroenterology & Urology · 266d
Cleared May 05, 2026
Healium Intelliscan LX192LC
K261132 · IYN
Healium Intelliscan Corporation
Radiology · 29d
Cleared May 05, 2026
AccelFix Spinal Fixation System
K261130 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 29d
Cleared May 05, 2026
Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP,...
K260742 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 60d
Cleared May 05, 2026
MectaLIF 3D Metal Anterior
K254202 · OVD
Medacta International S.A.
Orthopedic · 127d
Cleared May 05, 2026
Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1,...
K254200 · IRP
Wenzhou Lingfeng Electronic...
Physical Medicine · 127d
Cleared May 05, 2026
Lumify Diagnostic Ultrasound System
K252558 · IYN
Philips Ultrasound, LLC
Radiology · 265d
Cleared May 04, 2026
Neowise
K260716 · LLZ
Cefla S.C.
Radiology · 60d
Cleared May 04, 2026
Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)
K260688 · OLI
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 62d