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
9337–9360 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 05, 2023
Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL
K200583 · IOR
Ki Mobility, LLC
Physical Medicine · 1278d
Cleared Sep 01, 2023
InnerView LC
K232657 · EKX
Perimetrics, Inc.
Dental · 1d
Cleared Sep 01, 2023
Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor
K232340 · MBI
Arthrex, Inc.
Orthopedic · 28d
Cleared Sep 01, 2023
DEKA SIMON
K232334 · IPF
El.En S.P.A.
Physical Medicine · 28d
Cleared Sep 01, 2023
Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)
K232314 · FDS
Fujifilm Healthcare Americas Corporation
Gastroenterology & Urology · 30d
Cleared Sep 01, 2023
HyperLight Portable X-ray Unit
K232068 · EHD
Changzhou Sifary Medical Technology...
Radiology · 51d
Cleared Sep 01, 2023
Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T
K232021 · MOS
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 56d
Cleared Sep 01, 2023
CONDUIT™ ATP Inserters
K232014 · MAX
Enztec Limited
Orthopedic · 57d
Cleared Sep 01, 2023
TRIOCLEAR System
K231884 · NXC
Modern Dental Laboratory (Dg) Co., Ltd.
Dental · 66d
Cleared Sep 01, 2023
OW100S
K231710 · PZL
Softwave/Trt, LLC
General & Plastic Surgery · 81d
Cleared Sep 01, 2023
Montage Flowable Settable, Resorbable Bone Paste
K231270 · MQV
Orthocon, Inc.
Orthopedic · 122d
Cleared Sep 01, 2023
UniSyn Molecular Imaging (6-3-1)
K231047 · LLZ
Convergent Imaging Solutions
Radiology · 142d
Cleared Sep 01, 2023
MasterX 800 Series
K230918 · MQB
Medicatech USA
Radiology · 151d
Cleared Sep 01, 2023
TriMed Clavicle Fixation System
K230805 · HRS
TriMed, Inc.
Orthopedic · 162d
Cleared Sep 01, 2023
KITE Distal Fibula Kit
K230623 · HRS
Intrauma S.P.A
Orthopedic · 179d
Cleared Sep 01, 2023
Elos Accurate Hybrid Base
K230317 · NHA
Elos Medtech Pinol A/S
Dental · 207d
Cleared Sep 01, 2023
ApneaRX Pro
K223901 · LRK
Apnea Sciences Coporation
Dental · 247d
Cleared Sep 01, 2023
eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)
K223674 · KPE
Epic Medical Pte. , Ltd.
General Hospital · 268d
Cleared Sep 01, 2023
FaceHeart Vitals Software Development Kit (FH vitals SDK)
K223622 · QME
Faceheart Corp.
Cardiovascular · 270d
Cleared Sep 01, 2023
neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical
K222988 · ODP
Ht Medical D.B.A. Xenix Medical
Orthopedic · 338d
Cleared Sep 01, 2023
MS-39
K221601 · OBO
C.S.O. S.R.L.
Ophthalmic · 456d
Cleared Sep 01, 2023
Hemostatic Dressing
K213413 · QSY
Jiangsu Newvalue Medical Products...
General & Plastic Surgery · 682d
Cleared Sep 01, 2023
Brain Anesthesia Response Monitor (Bar Monitor)
K213273 · OLW
Cortical Dynamics , Ltd.
Anesthesiology · 701d
Cleared Aug 31, 2023
Powder Free Nitrile Examination Gloves (Black)
K232353 · LZA
Shanxi Hongjin Plastic Technology...
General Hospital · 24d