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
13297–13320 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 2022
iFuse-TORQ® Implant System
K213667 · OUR
SI-BONE, Inc.
Orthopedic · 200d
Cleared Jun 10, 2022
Pre-filled Syringe with Saline
K220060 · NGT
Jiangsu Caina Medical Co.,Ltd
General Hospital · 151d
Cleared Jun 10, 2022
Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System
K220319 · HWC
Stryker GmbH
Orthopedic · 127d
Cleared Jun 10, 2022
Saffron Fixation System
K220420 · PBQ
Coloplast A/S
Obstetrics & Gynecology · 116d
Cleared Jun 10, 2022
Surgical Isolation Cover Gown
K220528 · FYC
Wuhan Dymex Healthcare Co., Ltd.
General Hospital · 106d
Cleared Jun 10, 2022
IntellaMap Orion High Resolution Mapping Catheter
K220796 · DRF
Boston Scientific Corporation
Cardiovascular · 84d
Cleared Jun 10, 2022
SmileGuard
K220894 · MQC
Envisiontec GmbH
Dental · 74d
Cleared Jun 10, 2022
MediLab
K221065 · LLZ
Sigma Scientific Services, LLC
Radiology · 59d
Cleared Jun 10, 2022
Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4
K221087 · HAW
Medtronic Navigation, Inc.
Neurology · 58d
Cleared Jun 10, 2022
Omni Foot and Ankle Plating System
K221362 · HRS
Exremity Medical, LLC
Orthopedic · 30d
Cleared Jun 10, 2022
Nalu Neurostimulation System
K221376 · GZB
Boston Scientific Neuromodulation
Neurology · 29d
Cleared Jun 10, 2022
Swoop Portable MR Imaging System
K221393 · LNH
Hyperfine, Inc.
Radiology · 28d
Cleared Jun 10, 2022
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
K221658 · PBK
Centers For Disease Control and...
Microbiology · 2d
Cleared Jun 09, 2022
ACUTRON
K211000 · GEI
Ilooda Co,., Ltd.
General & Plastic Surgery · 433d
Cleared Jun 09, 2022
Cysto-Gastro-Sets
K211909 · KNS
G-Flex Europe Sprl
Gastroenterology & Urology · 353d
Cleared Jun 09, 2022
KHEIRON® Spinal Fixation System
K211981 · NKB
S.M.A.I.O
Orthopedic · 349d
Cleared Jun 09, 2022
HELIOS IV 785
K212663 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 290d
Cleared Jun 09, 2022
Nasogastric Feeding Tubes - ENFit Port - PVC
K213258 · PIF
Cair Lgl
Gastroenterology & Urology · 252d
Cleared Jun 09, 2022
MyCRO Band
K213587 · MVA
Otto Bock Healthcare LP
Neurology · 209d
Cleared Jun 09, 2022
ALLY Adaptive Cataract Treatment System
K220259 · OOE
Lensar, Inc.
Ophthalmic · 129d
Cleared Jun 09, 2022
RedPoint Medical's Better Bunion System
K220717 · PBF
Redpoint Medical, LLC
Orthopedic · 90d
Cleared Jun 09, 2022
The Luminance RED Acne Device
K220729 · OLP
Luminance Medical Ventures, Inc.
General & Plastic Surgery · 87d
Cleared Jun 09, 2022
IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System,...
K220782 · MAX
Alphatec Spine, Inc.
Orthopedic · 84d
Cleared Jun 09, 2022
EksoNR
K220988 · PHL
Ekso Bionics, Inc.
Neurology · 66d