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
12433–12456 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 22, 2022
SurGuard3 Safety Hypodermic Needle
K212095 · FMI
Terumo Europe N.V.
General Hospital · 412d
Cleared Aug 22, 2022
Auxilock Draw Tight Suture-Based Anchor
K213109 · MBI
Auxein Medical Private Limited
Orthopedic · 332d
Cleared Aug 22, 2022
VPS Rhythm DLX Device with TipTracker Technology
K220363 · LJS
Arrow International, LLC (A...
General Hospital · 195d
Cleared Aug 22, 2022
ClearCalc Model RADCA V2
K220582 · MUJ
Radformation, Inc.
Radiology · 174d
Cleared Aug 22, 2022
Arthrex FiberTape and TigerTape Cerclage Sutures
K221485 · HTN
Arthrex, Inc.
General & Plastic Surgery · 91d
Cleared Aug 22, 2022
Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy...
K221528 · DXF
Edwards Lifesciences, LLC
Cardiovascular · 88d
Cleared Aug 22, 2022
HS40 Diagnostic Ultrasound System
K221599 · IYN
Samsung Medison Co., Ltd.
Radiology · 81d
Cleared Aug 22, 2022
SafetiHeel, MediHeel, Novaplus
K221604 · FMK
Nsp Tech Pte, Ltd.
General & Plastic Surgery · 81d
Cleared Aug 22, 2022
SABER .014 PTA Dilatation Catheter
K221832 · LIT
Cordis US Corp
Cardiovascular · 60d
Cleared Aug 22, 2022
CUSA Clarity Ultrasonic Surgical Aspirator System
K221835 · LFL
Integra LifeSciences Corporation
General & Plastic Surgery · 60d
Cleared Aug 19, 2022
CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW
K203078 · FXX
Huizhou Tianchang Industrial Co., Ltd.
General Hospital · 675d
Cleared Aug 19, 2022
Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices
K212525 · LHI
Advcare Medical
General Hospital · 373d
Cleared Aug 19, 2022
Bonvadis Topical Cream
K212554 · FRO
Stemcyte, Inc.
General & Plastic Surgery · 371d
Cleared Aug 19, 2022
AXIR-CX
K213520 · LLZ
Radisen Co., Ltd.
Radiology · 289d
Cleared Aug 19, 2022
Lexa PLUS RIS-311
K213758 · FLE
W&H Sterilization S.R.L.
General Hospital · 262d
Cleared Aug 19, 2022
Percent Oxygen Sensors
K213933 · CCL
Careox, LLC
Anesthesiology · 246d
Cleared Aug 19, 2022
Viramed Borrela All-In-One ViraChip Test Kit
K220016 · LSR
Viramed Biotech AG
Microbiology · 226d
Cleared Aug 19, 2022
BD MAX Enteric Parasite Panel
K220193 · PCH
Becton, Dickinson and Company
Microbiology · 207d
Cleared Aug 19, 2022
Disposable Endoscope Injection Needle
K220292 · FBK
Yangzhou Fartley Medical Instrument...
Gastroenterology & Urology · 199d
Cleared Aug 19, 2022
SmartAdjust(TM) technology
K220394 · QJI
Insulet Corporation
Chemistry · 189d
Cleared Aug 19, 2022
uCerv Flux-C 3D Porous Titanium Cervical Interbody
K220696 · ODP
Ulrich Medical USA
Orthopedic · 163d
Cleared Aug 19, 2022
DynaClip® Bone Staple
K220812 · JDR
MedShape, Inc.
Orthopedic · 151d
Cleared Aug 19, 2022
Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman...
K221023 · PEK
Spinal Simplicity, LLC
Orthopedic · 135d
Cleared Aug 19, 2022
REAL INTELLIGENCE CORI
K221224 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 113d