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
8881–8904 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 2023
R2GATE Lite TM
K223909 · LLZ
Megagen Implant Co., Ltd.
Radiology · 295d
Cleared Oct 20, 2023
SPECTRALIS HRA+OCT and variants
K223557 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 329d
Cleared Oct 19, 2023
CombiDiagnost R90
K232910 · JAA
Philips Medical Systems Dmc GmbH
Radiology · 30d
Cleared Oct 19, 2023
Medline UNITE® REFLEX® Nitinol Staple Kit
K232905 · JDR
Medline Industries, LP
Orthopedic · 30d
Cleared Oct 19, 2023
KeyLift™ Expandable Interlaminar Stabilization System
K232484 · PEK
Flospine
Orthopedic · 64d
Cleared Oct 19, 2023
Actinia® hip stems
K232371 · LZO
Implantcast GmbH
Orthopedic · 72d
Cleared Oct 19, 2023
StealthStation Cranial Software, v3.1.5 (9735585)
K231976 · HAW
Medtronic Navigation, Inc.
Neurology · 108d
Cleared Oct 19, 2023
Radio Frequency System
K231749 · GEI
Shenzhenshi Sincoheren S&T...
General & Plastic Surgery · 126d
Cleared Oct 19, 2023
Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System
K231704 · OVE
Life Spine, Inc.
Orthopedic · 129d
Cleared Oct 19, 2023
IRRAflow Active Fluid Exchange System (AFES)
K231664 · JXG
Irras USA, Inc.
Neurology · 134d
Cleared Oct 19, 2023
Xpert Xpress MVP
K231381 · PQA
Cepheid
Microbiology · 160d
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