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
11257–11280 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 23, 2022
Smartpump 3.0 Double Electric Breast Pump
K222726 · HGX
Lansinoh Laboratories
Obstetrics & Gynecology · 106d
Cleared Dec 23, 2022
ShiNeo Silicone Implant
K222748 · MIB
Shineo Technology Co., Ltd.
General & Plastic Surgery · 102d
Cleared Dec 23, 2022
Leg Massager RF-ALM070
K222924 · IRP
Shenzhen Ruiyi Business Technology...
Physical Medicine · 88d
Cleared Dec 23, 2022
Xenoview VDP
K223071 · LLZ
Polarean, Inc.
Radiology · 84d
Cleared Dec 23, 2022
Access Vitamin B12
K223289 · CDD
Beckman Coulter, Inc.
Chemistry · 59d
Cleared Dec 23, 2022
MR 5300 and MR 7700 R11 MR Systems
K223442 · LNH
Philips Medical Systems Nederlands B.V.
Radiology · 39d
Cleared Dec 23, 2022
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal...
K223565 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 24d
Cleared Dec 22, 2022
Lp(a) Ultra
K211058 · DFC
SENTINEL CH. SpA
Chemistry · 622d
Cleared Dec 22, 2022
SteriKing LT-Blueline Pouches with Tyvek
K221377 · FRG
Wipak OY
General Hospital · 224d
Cleared Dec 22, 2022
Arthrex FiberTak Suture Anchor
K221396 · MBI
Arthrex, Inc.
Orthopedic · 223d
Cleared Dec 22, 2022
PerioStom Dental Dressing
K221428 · OLR
Forward Science, LLC
General & Plastic Surgery · 220d
Cleared Dec 22, 2022
TruWave Disposable Pressure Transducer
K222216 · DXO
Edwards Lifesciences, LLC
Cardiovascular · 150d
Cleared Dec 22, 2022
Sunrise
K222262 · QRS
Sunrise SA
Anesthesiology · 147d
Cleared Dec 22, 2022
iFuse Bedrock Granite® Implant System
K222774 · OUR
SI-BONE, Inc.
Orthopedic · 99d
Cleared Dec 22, 2022
Kodiak C Spinal Implant System
K222806 · ODP
Met One Technologies, LLC
Orthopedic · 97d
Cleared Dec 22, 2022
Invisalign System, Pre-Formed Attachment System
K222894 · NXC
Align Technology, Inc.
Dental · 90d
Cleared Dec 22, 2022
Air Compression Leg Massager (Model: LY-670D)
K222949 · IRP
Zhejiang Luyao Electronics Technology...
Physical Medicine · 86d
Cleared Dec 22, 2022
Tesera-K SC System
K223105 · OVE
Kyocera Medical Technologies, Inc.
Orthopedic · 83d
Cleared Dec 22, 2022
Coltolux Comfort LED Curing Light
K223142 · EBZ
Dent4you AG
Dental · 79d
Cleared Dec 22, 2022
ASTRA Spine System
K223273 · NKB
Spinecraft, LLC
Orthopedic · 59d
Cleared Dec 22, 2022
Philips CT 3500
K223311 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 55d
Cleared Dec 22, 2022
Cardioblate Gemini-s 49260 Surgical Ablation Device
K223508 · OCL
Medtronic, Inc.
Cardiovascular · 30d
Cleared Dec 22, 2022
Biograph Vision Quadra PET/CT System
K223547 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Dec 22, 2022
VERTICALE® Navigation Instruments
K223649 · OLO
Silony Medical GmbH
Orthopedic · 16d