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
12913–12936 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 23, 2022
BreathID Hp Lab System, BreathID Smart System
K220494 · MSQ
Meridian Bioscience Israel , Ltd.
Microbiology · 121d
Cleared Jun 23, 2022
CoLumbo
K220497 · QIH
Smart Soft Healthcare AD
Radiology · 121d
Cleared Jun 23, 2022
bite away neo
K220514 · IRT
mibeTec GmbH
Physical Medicine · 121d
Cleared Jun 23, 2022
Mural Perinatal Surveillance
K220732 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 101d
Cleared Jun 23, 2022
Introcan Safety 2 IV Catheter
K220756 · FOZ
B.Braun Medical, Inc.
General Hospital · 100d
Cleared Jun 23, 2022
Ultrasound System SONIMAGE MX1
K220993 · IYN
Konica Minolta, Inc.
Radiology · 80d
Cleared Jun 23, 2022
ZEPTO Precision Capsulotomy System
K221188 · PUL
Centricity Vision, Inc.
Ophthalmic · 59d
Cleared Jun 23, 2022
Excipio SV Thrombectomy Device
K221204 · QEW
Contego Medical, Inc.
Cardiovascular · 58d
Cleared Jun 23, 2022
Axial3D Cloud Segmentation Service
K221511 · LLZ
Axial Medical Printing Limited
Radiology · 30d
Cleared Jun 22, 2022
Klassic Knee System
K211877 · JWH
Total Joint Orthopedics, Inc.
Orthopedic · 370d
Cleared Jun 22, 2022
Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711),...
K212665 · DQA
Huizhou Xiaoou Technology Co., Ltd.
Anesthesiology · 303d