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
913–936 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Apr 27, 2026
Avenir® Müller Stem
K260182 · LZO
Zimmer, Inc.
Orthopedic · 96d
Cleared Apr 27, 2026
STA Satellite Max®
K253658 · JPA
Diagnostica Stago, Inc.
Hematology · 158d
Cleared Apr 27, 2026
Pelvic Floor Exerciser (PF01)
K252748 · HIR
Hunan Accurate Bio-Medical Technology...
Gastroenterology & Urology · 241d
Cleared Apr 27, 2026
CASSIE
K252628 · MNR
Wesper, Inc.
Anesthesiology · 250d
Cleared Apr 27, 2026
Fusion Bioline Vascular Graft
K252445 · DSY
Maquet Cardiovascular, LLC
Cardiovascular · 266d
Cleared Apr 27, 2026
TearCare MGX System
K252409 · ORZ
Sight Sciences, Inc.
Ophthalmic · 269d
Cleared Apr 26, 2026
Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S)
K253580 · PDQ
Tedan Surgical Innovations
Neurology · 160d
Cleared Apr 24, 2026
AUTOBAHN™ Nailing System
K261043 · HSB
Globus Medical, Inc.
Orthopedic · 24d
Cleared Apr 24, 2026
Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip
K261008 · MQV
Stryker Spine
Orthopedic · 29d
Cleared Apr 24, 2026
LoFric Elle Pro
K260999 · EZD
Wellspect AB
Gastroenterology & Urology · 29d
Cleared Apr 24, 2026
Amplatzer TorqVue Delivery System
K260993 · DQY
Abbott
Cardiovascular · 29d
Cleared Apr 24, 2026
°M Warmer System with °M Station
K260988 · LGZ
Mequ A/S
General Hospital · 30d
Cleared Apr 24, 2026
Alexis lighted wound protector-retractor, flexible, extra small (cl312)
K260982 · KGW
Applied Medical Resources Corporation
General & Plastic Surgery · 30d
Cleared Apr 24, 2026
INDIGO® Aspiration System – INDIGO Link
K260599 · QEW
Penumbra, Inc.
Cardiovascular · 59d
Cleared Apr 24, 2026
ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System
K260549 · ODP
Zsfab, Inc.
Orthopedic · 65d
Cleared Apr 24, 2026
Control-IQ+ technology
K260429 · QJI
Tandem Diabetes Care, Inc.
Chemistry · 73d
Cleared Apr 24, 2026
PC Fix System
K260411 · HRS
Chest Wall Innovations, Inc.
Orthopedic · 74d
Cleared Apr 24, 2026
POYA 3.5mm Medial Proximal Tibia System
K260228 · HRS
Bonebridge AG
Orthopedic · 88d
Cleared Apr 24, 2026
I.T.S. PRS Phoenix II
K260054 · HRS
I.T.S. GmbH
Orthopedic · 106d
Cleared Apr 24, 2026
LungPoint Virtual Bronchoscopic Navigation (VBN) Software
K260009 · LLZ
Broncus Medical, Inc.
Radiology · 112d
Cleared Apr 24, 2026
ARTIS icono floor
K254173 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 122d
Cleared Apr 24, 2026
Dilation Balloon Catheter
K253832 · FGE
Mirco-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 144d
Cleared Apr 24, 2026
Knee+
K253805 · SBF
Pixee Medical S.A.S.
Orthopedic · 147d
Cleared Apr 24, 2026
OPTIS Mobile Next Imaging System (1014932)
K253459 · NQQ
Abbott Medical
Cardiovascular · 199d