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
8617–8640 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 19, 2023
Acro Composites Interbody System
K230478 · ODP
Acro Composites, LLC
Orthopedic · 239d
Cleared Oct 19, 2023
Oran Park Mask
K230476 · BZD
Resmed Pty Ltd (Registration Number:...
Anesthesiology · 239d
Cleared Oct 19, 2023
C.C. Life 21
K230459 · NFO
21 Equipment S.R.L.
Neurology · 240d
Cleared Oct 19, 2023
EasyOne Sky Spirometer
K230178 · BZG
Ndd Medizintechnik AG
Anesthesiology · 269d
Cleared Oct 18, 2023
T-Line® Hernia Mesh
K232924 · FTL
Deep Blue Medical Advances, Inc.
General & Plastic Surgery · 29d
Cleared Oct 18, 2023
Arthrex Small External Fixation System
K232897 · KTT
Arthrex, Inc.
Orthopedic · 30d
Cleared Oct 18, 2023
Millipede 070 Aspiration Catheter
K232524 · NRY
Perfuze, Ltd.
Neurology · 61d
Cleared Oct 18, 2023
MectaLIF Anterior Lag Extension
K232123 · OVD
Medacta International S.A.
Orthopedic · 93d
Cleared Oct 18, 2023
Medline Safety Insulin and TB Syringes
K231907 · MEG
Medline Industries, LP
General Hospital · 111d
Cleared Oct 18, 2023
Omnipod 5 ACE Pump
K231826 · QFG
Insulet Corporation
Chemistry · 119d
Cleared Oct 18, 2023
SmartBolus Calculator
K231824 · QRX
Insulet Corporation
Chemistry · 119d
Cleared Oct 18, 2023
OptiMesh Multiplanar Expandable Interbody Fusion System
K231781 · OQB
Spineology, Inc.
Orthopedic · 124d
Cleared Oct 18, 2023
INNO SLA Submerged Narrow Implant System
K231395 · DZE
Cowellmedi Co., Ltd.
Dental · 156d
Cleared Oct 18, 2023
EConsole1
K231225 · LLZ
DRTECH Corporation
Radiology · 173d
Cleared Oct 18, 2023
Terumo Injection Filter Needle (NF-3013RBKE05M)
K230951 · QYM
Terumo Europe N.V.
General Hospital · 197d
Cleared Oct 18, 2023
Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)
K230702 · CAW
Qingdao Kingon Medical Science and...
Anesthesiology · 218d
Cleared Oct 18, 2023
Byte Aligner System
K230199 · NXC
Dentsply Sirona, Inc.
Dental · 266d
Cleared Oct 17, 2023
Legend X Platform
K232903 · GEI
Pollogen, Ltd.
General & Plastic Surgery · 29d
Cleared Oct 17, 2023
TransLoc 3D
K232878 · OUR
Foundation Fusion Solutions, LLC (Dba...
Orthopedic · 29d
Cleared Oct 17, 2023
Dynamic TiBase
K232151 · NHA
Talladium Espa?a, SL
Dental · 90d
Cleared Oct 17, 2023
SOZO Pro
K232089 · DSB
ImpediMed Limited
Gastroenterology & Urology · 96d
Cleared Oct 17, 2023
HAtetracell™-C Titanium Cervical IBF System
K231899 · ODP
Innovasis, Inc.
Orthopedic · 111d
Cleared Oct 17, 2023
Infinity CentralStation Wide, Infinity M300, Infinity M300+
K231477 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 148d
Cleared Oct 17, 2023
Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)
K231105 · FBN
Shanghai AnQing Medical Instrument...
Gastroenterology & Urology · 181d