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: Cleared only ×
175,230 results
10585–10608 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 19, 2023
ART-Plan
K230023 · QKB
Therapanacea Sas
Radiology · 105d
Cleared Apr 19, 2023
SimpliFix Hip System
K230053 · HWC
Stabiliz Orthopaedics, Inc.
Orthopedic · 103d
Cleared Apr 19, 2023
Diode Laser Hair Removal
K230090 · OHT
Wuhan Lotuxs Technology Co., Ltd.
General & Plastic Surgery · 97d
Cleared Apr 19, 2023
Altus Spine Monaco Pedicle Screw System
K230766 · NKB
Altus Spine
Orthopedic · 30d
Cleared Apr 18, 2023
SENSOSEEG Depth Electrodes
K213170 · GZL
Sensomedical Labs, Ltd.
Neurology · 567d
Cleared Apr 18, 2023
Terumo Advanced Perfusion System 1
K221895 · DTQ
Terumo Cardiovascular Systems...
Cardiovascular · 292d
Cleared Apr 18, 2023
UniVy™ OsteoVy™-Ti Cervical IBF System
K223513 · ODP
Vy Spine, LLC
Orthopedic · 147d
Cleared Apr 18, 2023
Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200
K223784 · GEI
Deltronix Equipamentos Ltda
General & Plastic Surgery · 123d
Cleared Apr 18, 2023
ClotTriever BOLD Catheter
K230494 · QEW
Inari Medical, Inc.
Cardiovascular · 54d
Cleared Apr 18, 2023
Anivia SG1000 Pump Console
K230698 · DWA
Apmtd, Inc.
Cardiovascular · 36d
Cleared Apr 18, 2023
OsteoCentric Integrated Hip Fastener System
K230764 · JDO
OsteoCentric Technologies
Orthopedic · 29d
Cleared Apr 18, 2023
SofWave System
K230820 · OHV
Sofwave Medical, Ltd.
General & Plastic Surgery · 25d
Cleared Apr 17, 2023
TIB Abutments
K222469 · NHA
Southern Implants (Pty), Ltd.
Dental · 244d
Cleared Apr 17, 2023
Curian® Shiga Toxin
K222829 · GMZ
Meridian Bioscience, Inc.
Microbiology · 210d
Cleared Apr 17, 2023
Custom-made Invisible Aligners
K223454 · NXC
Zhejiang Yinchili Medical Technology...
Dental · 152d
Cleared Apr 17, 2023
X-CUBE 50, X-CUBE 60
K223564 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 139d
Cleared Apr 17, 2023
Localite TMS Navigator TS
K223577 · HAW
Localite GmbH
Neurology · 138d
Cleared Apr 17, 2023
Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization...
K230429 · NRY
Rapid Medical , Ltd.
Neurology · 59d
Cleared Apr 17, 2023
SnugFit All-Suture Anchor extension
K230544 · MBI
Medacta International S.A.
Orthopedic · 48d
Cleared Apr 17, 2023
TriMed Threaded Intramedullary Nail System
K230749 · HWC
TriMed, Inc.
Orthopedic · 31d
Cleared Apr 17, 2023
Quantib Prostate
K230772 · LLZ
Quantib B.V.
Radiology · 27d
Cleared Apr 16, 2023
Masimo Rad-G with Temperature
K213676 · DQA
Masimo Corporation
Anesthesiology · 510d
Cleared Apr 16, 2023
EpiFinder
K221974 · FMF
Omeq Medical , Ltd.
Anesthesiology · 285d
Cleared Apr 14, 2023
STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for...
K220345 · MLR
Plasmapp Co,., Ltd.
General Hospital · 431d