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
12721–12744 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 18, 2022
Vivid T8, Vivid T9
K221147 · IYN
GE Medical Systems Ultrasound and...
Radiology · 89d
Cleared Jul 18, 2022
Vivid iq
K221148 · IYN
GE Medical Systems Ultrasound &...
Radiology · 89d
Cleared Jul 18, 2022
PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.
K221803 · IZL
Sedecal., Sa.
Radiology · 26d
Cleared Jul 16, 2022
0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub
K213955 · QTI
Becton, Dickinson and Company
General Hospital · 211d
Cleared Jul 16, 2022
Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder...
K221229 · LZA
Zibo Blue Sail Health Technology Co.,...
General Hospital · 78d
Cleared Jul 15, 2022
Nerve Tape
K210665 · JXI
Biocircuit Technologies, Incorporated
Neurology · 497d
Cleared Jul 15, 2022
Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No....
K212778 · QLX
Abbott Molecular, Inc.
Microbiology · 317d
Cleared Jul 15, 2022
ers2 - ergoline Rehabilitation System
K212883 · DRG
Ergoline GmbH
Cardiovascular · 308d
Cleared Jul 15, 2022
Tatum Surgical Dental Implant System
K213576 · DZE
Suncoast Dental, Inc. Dba Tatum Surgical
Dental · 247d
Cleared Jul 15, 2022
ComPAS2
K213872 · BZG
Morgan Scientific, Inc.
Anesthesiology · 214d
Cleared Jul 15, 2022
Kontact Dental Implant System
K213997 · DZE
Biotech Dental, Sas
Dental · 206d
Cleared Jul 15, 2022
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar,...
K220127 · OBP
Neuronetics, Inc.
Neurology · 178d
Cleared Jul 15, 2022
Vivid S60N, Vivid S70N
K220619 · IYN
GE Medical Systems Ultrasound and...
Radiology · 134d
Cleared Jul 15, 2022
Hailie Sensor NF0106
K220622 · CAF
Adherium (Nz), Ltd.
Anesthesiology · 134d
Cleared Jul 15, 2022
NomadAir PMU810
K220631 · GWL
Neurotronics, Inc.
Neurology · 133d
Cleared Jul 15, 2022
NxtGen Infant Transport Incubator
K220742 · FPL
International Biomedical
General Hospital · 123d
Cleared Jul 15, 2022
Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems
K220877 · HQF
Lumenis Be, Inc.
Ophthalmic · 112d
Cleared Jul 15, 2022
Renuvion APR Handpiece
K220970 · GEI
Apyx Medical Corporation(Formerly...
General & Plastic Surgery · 102d
Cleared Jul 15, 2022
Model 9100 PFT/DICO
K221030 · BTY
Vitalograph (Ireland) , Ltd.
Anesthesiology · 99d
Cleared Jul 15, 2022
Facet 28G Universal Lancet
K221433 · QRK
Facet Technologies, LLC
General & Plastic Surgery · 59d
Cleared Jul 15, 2022
CUSA Clarity Ultrasonic Surgical Aspirator System
K221763 · LFL
Integra LifeSciences Corporation
General & Plastic Surgery · 28d
Cleared Jul 15, 2022
OK Handpiece
K221814 · EFB
Jaintek Co.,Ltd
Dental · 23d
Cleared Jul 15, 2022
Digital Radiography CXDI-Pro, Digital Radiography D1
K221876 · MQB
Canon, Inc.
Radiology · 17d
Cleared Jul 14, 2022
AGNES
K203013 · GEI
Agnes Medical Co., Ltd.
General & Plastic Surgery · 651d