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
1657–1680 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Feb 06, 2026
Athelas Home
K243348 · GKZ
Athelas, Inc.
Hematology · 466d
Not Cleared Feb 06, 2026
Amferia Wound Dressing
DEN250006 · SHA
Amferia AB
General & Plastic Surgery · 340d
Cleared Feb 05, 2026
CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with...
K260028 · QEW
Argon Medical Devices, Inc.
Cardiovascular · 31d
Cleared Feb 05, 2026
Primevision 3D
K253959 · OAS
Dentsply Sirona
Radiology · 57d
Cleared Feb 05, 2026
SIGNA™ Sprint Select
K253779 · LNH
Ge Medical Systems, LLC
Radiology · 71d
Cleared Feb 05, 2026
INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
K251949 · QEW
Penumbra, Inc.
Cardiovascular · 225d
Cleared Feb 05, 2026
Encora X1
K251517 · QBC
Encora, Inc.
Neurology · 265d
Cleared Feb 04, 2026
Signature™ ONE System
K260104 · QHE
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 22d
Cleared Feb 04, 2026
E3D™-C Interbody System
K260038 · OVE
Evolution Spine
Orthopedic · 29d
Cleared Feb 04, 2026
UltraScore™ Focused Force PTA Balloon
K260012 · PNO
Bard Peripheral Vascular, Inc.
Cardiovascular · 30d
Cleared Feb 04, 2026
G7® Revision Acetabular System
K252623 · LPH
Zimmer, Inc.
Orthopedic · 169d
Cleared Feb 04, 2026
Henan Yadu Level 4 Surgical Gowns (Reinforced)
K252301 · FYA
Yadu Medical (Henan) Co., Ltd.
General Hospital · 195d
Cleared Feb 04, 2026
Luna® Ti Interbody Fusion System
K250773 · MAX
Spinal Elements, Inc.
Orthopedic · 327d
Cleared Feb 03, 2026
Dexcom G7 Continuous Glucose Monitoring (CGM) System
K253737 · QBJ
Dexcom, Inc.
Chemistry · 71d
Cleared Feb 03, 2026
SmartGuard Technology
K253701 · QJI
Medtronic Minimed
Chemistry · 71d
Cleared Feb 03, 2026
T2 Alpha Femur Retrograde Nailing System
K253640 · HSB
Stryker GmbH
Orthopedic · 76d
Cleared Feb 03, 2026
ZSmile System
K253282 · NXC
Dror Orthodesign , Ltd.
Dental · 127d
Cleared Feb 03, 2026
Diagnostic X-Ray Equipment Model POCT22
K252909 · EHD
Ningbo Runyes Medical Instrument Co.,...
Radiology · 144d
Cleared Feb 03, 2026
The Circadia C300 System (C300)
K252676 · DRT
Circadia Health, Inc.
Cardiovascular · 162d
Cleared Feb 03, 2026
Explant Express
K252438 · QVS
Applied Medical Technology, Inc.
General & Plastic Surgery · 186d
Cleared Feb 03, 2026
Navigation Module of the Cortium® System
K252087 · OLO
Ulrich Medical USA, Inc.
Orthopedic · 216d
Cleared Feb 03, 2026
808nm semiconductor laser hair removal machine
K252048 · GEX
Xi'An Taibo Electronic Technology...
General & Plastic Surgery · 218d
Cleared Feb 03, 2026
MSS - Monobloc stem
K250644 · PHX
Medacta International S.A.
Orthopedic · 336d
Cleared Feb 02, 2026
TAP2D
K252649 · IZF
Nano-X Imaging , Ltd.
Radiology · 165d