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
13177–13200 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 2022
DT-703
K221233 · EHD
Ecotron Co., Ltd.
Radiology · 59d
Cleared Jun 24, 2022
RoughRider Aurora Manual Wheelchair
K200715 · IOR
Roughrider America, LLC
Physical Medicine · 828d
Cleared Jun 24, 2022
Noris Medical Dental Implants System - Cortical
K210852 · DZE
Noris Medical , Ltd.
Dental · 459d
Cleared Jun 24, 2022
TRAUS ENDO
K212043 · EKX
Saeshin Precision Co., Ltd.
Dental · 359d
Cleared Jun 24, 2022
EZYPOR
K212741 · HPZ
Fci (France Chirurgie...
Ophthalmic · 298d
Cleared Jun 24, 2022
BentrioTM Allergy Blocker
K213114 · NUP
Altamira Therapeutics, Inc.
Ear, Nose, Throat · 270d
Cleared Jun 24, 2022
Secret Duo
K213250 · GEX
Ilooda Co,., Ltd.
General & Plastic Surgery · 267d
Cleared Jun 24, 2022
FlexBoardTM, EagleBoardTM, BreastBoard SXTM
K213439 · IYE
Macromedics BV
Radiology · 242d
Cleared Jun 24, 2022
Intelligence LaserComb
K213789 · OAP
Yibin Yingtong Intelligent Technology...
General & Plastic Surgery · 200d
Cleared Jun 24, 2022
T-FIX® 3DSI Joint Fusion System
K214123 · OUR
Cutting Edge Spine, LLC
Orthopedic · 176d
Cleared Jun 24, 2022
OTOPLAN
K220300 · QQE
Cascination AG
Ear, Nose, Throat · 142d
Cleared Jun 24, 2022
Procedure Mask
K220377 · FXX
Little Rapids Corporation
General Hospital · 134d
Cleared Jun 24, 2022
MAGNETOM Free.Max, MAGNETOM Free.Star
K220575 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 116d
Cleared Jun 24, 2022
ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
K220801 · OZE
Abbott Diagnostics Scarborough, Inc.
Microbiology · 98d
Cleared Jun 24, 2022
3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)
K220942 · JOJ
3M Company
General Hospital · 85d
Cleared Jun 24, 2022
Sugita AVM Microclip Applier
K221524 · HCI
Mizuho America, Inc.
Neurology · 29d
Cleared Jun 24, 2022
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
K221834 · PBK
Centers For Disease Control and...
Microbiology · 1d
Cleared Jun 23, 2022
EDEN Spinal Fixation System
K201788 · NKB
Jmt Co., Ltd.
Orthopedic · 723d
Cleared Jun 23, 2022
maxmorespine Bipolar Electrodes
K211173 · GEI
Hoogland Spine Products, GmbH
General & Plastic Surgery · 429d
Cleared Jun 23, 2022
HD Mediastinoscope
K213194 · EWY
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 267d
Cleared Jun 23, 2022
EZYPRO ECG Recorder (Model: UG02)
K213233 · DRG
Sigknow Biomedical Co., Ltd.
Cardiovascular · 266d
Cleared Jun 23, 2022
CORE-CLIP
K213338 · PKL
Incore Co., Ltd.
Gastroenterology & Urology · 259d
Cleared Jun 23, 2022
Catalyst R1 Reverse Shoulder System
K213349 · PHX
Catalyst Orthoscience, Inc.
Orthopedic · 258d
Cleared Jun 23, 2022
SYLFIRM X
K213612 · GEI
VIOL Co., Ltd.
General & Plastic Surgery · 220d