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
13705–13728 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 2022
Hand Diagnostic Radiography Imaging System
K220271 · KPR
Nanoray Biotech Co., Ltd.
Radiology · 88d
Cleared Apr 29, 2022
ARIETTA 50
K220295 · IYN
Fujifilm Healthcare Corporation
Radiology · 86d
Cleared Apr 29, 2022
ExacTrac Dynamic
K220338 · IYE
Brainlab AG
Radiology · 81d
Cleared Apr 29, 2022
LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9)
K220383 · KRD
Okami Medical
Cardiovascular · 78d
Cleared Apr 29, 2022
Spectrum IQ Infusion System with Dose IQ Safety Software
K220417 · FRN
Baxter Healthcare Corporation
General Hospital · 74d
Cleared Apr 29, 2022
aPROMISE X
K220590 · LLZ
Exini Diagnostics AB
Radiology · 59d
Cleared Apr 29, 2022
Accu-Chek FastClix Blood Lancing System
K220608 · QRL
Roche Diabetes Care, Inc.
General & Plastic Surgery · 58d
Cleared Apr 29, 2022
Oryx Cloud Imaging
K220684 · LLZ
Oryx Dental Software, Inc.
Radiology · 52d
Cleared Apr 29, 2022
Elite Biomedical Solutions Dose Request Cord
K220695 · MRZ
Elite Biomedical Solutions
General Hospital · 51d
Cleared Apr 29, 2022
Oxehealth Vital Signs
K220899 · QME
Oxehealth Limited
Cardiovascular · 32d
Cleared Apr 29, 2022
MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A
K220939 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Apr 29, 2022
EEA Circular Stapler with Tri-Staple Technology
K221005 · GDW
Covidien
General & Plastic Surgery · 24d
Cleared Apr 29, 2022
GIA Stapler with Tri-Staple Technology
K221006 · GDW
Covidien
General & Plastic Surgery · 24d
Cleared Apr 28, 2022
Ortholock Anchorage Devices
K202691 · OAT
Craniofacial Technologies, Inc.
Dental · 590d
Cleared Apr 28, 2022
AngioCloud Service
K211713 · LLZ
Angiocloud, LLC
Radiology · 329d
Cleared Apr 28, 2022
RetinAI Discovery
K211715 · NFJ
Retinai Medical AG
Ophthalmic · 329d
Cleared Apr 28, 2022
EARP Interbody System
K212477 · MAX
Nvision Biomedical Technologies, Inc.
Orthopedic · 262d
Cleared Apr 28, 2022
G7® Vivacit-E® Freedom® Constrained Liner
K212512 · PBI
Zimmer, Inc.
Orthopedic · 261d
Cleared Apr 28, 2022
Planmed Verity
K213278 · OAS
Planmed OY
Radiology · 209d
Cleared Apr 28, 2022
Geistlich Wound Matrix PLUS
K213607 · KGN
Geistlich Pharma AG
General & Plastic Surgery · 164d
Cleared Apr 28, 2022
Microthin Natural Rubber Latex Condom
K213921 · HIS
Suretex Limited
Obstetrics & Gynecology · 134d
Cleared Apr 28, 2022
DVR® Crosslock Wrist Spanning Plate (131849181)
K220244 · HRS
Pioneer Surgical Technology, Inc...
Orthopedic · 90d
Cleared Apr 28, 2022
EFAI RTSuite CT HN-Segmentation System
K220264 · QKB
Ever Fortune.Ai, Co., Ltd.
Radiology · 87d
Cleared Apr 28, 2022
Digital flat panel detector
K220536 · MQB
Iray Technology Taicang , Ltd.
Radiology · 63d