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
9073–9096 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 31, 2023
RAYSCAN a-Expert3D
K232287 · OAS
Ray Co., Ltd.
Radiology · 30d
Cleared Aug 31, 2023
BioSieve™ Marijuana Test Panel 50
K231978 · NFW
Vivachek Biotech (Hangzhou) Co., Ltd.
Toxicology · 59d
Cleared Aug 31, 2023
OSPREY Closed IV Catheter System (OspreyV2)
K231626 · FOZ
Skydance Vascular, Inc.
General Hospital · 90d
Cleared Aug 31, 2023
ZEUS IFA(TM) nDNA Test System, ZEUS dIFine
K231616 · KTL
Zeus Scientific
Immunology · 90d
Cleared Aug 31, 2023
HOLO Portal™ Surgical Guidance System
K231611 · SBF
Surgalign Spine Technologies
Orthopedic · 90d
Cleared Aug 31, 2023
The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution...
K231433 · NGZ
Thermo Fisher Scientific
Microbiology · 106d
Cleared Aug 31, 2023
Ancora-SB
K231323 · FDA
Aspero Medical, Inc.
Gastroenterology & Urology · 115d
Cleared Aug 31, 2023
Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use...
K230578 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 183d
Cleared Aug 31, 2023
EL27-Compact
K230488 · FFK
Walz Elektronik GmbH
Gastroenterology & Urology · 189d
Cleared Aug 31, 2023
23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for...
K223597 · QAZ
23AndMe, Inc.
Pathology · 272d
Cleared Aug 31, 2023
Little Wave Arc
K223533 · LBE
Ki Mobility, LLC
Physical Medicine · 281d