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
13009–13032 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 14, 2022
Alma Diode Tabletop Laser
K212073 · GEX
Alma Lasers , Ltd.
General & Plastic Surgery · 377d
Cleared Jul 14, 2022
PELNAC Meshed Bilayer Wound Matrix
K213498 · KGN
Gunze Limited
General & Plastic Surgery · 255d
Cleared Jul 14, 2022
LIAISON MeMed BV, LIAISON MeMed BV Control Set
K213936 · QPS
DiaSorin, Inc.
Microbiology · 210d
Cleared Jul 14, 2022
TruAbutment DS, TruBase
K213961 · NHA
Truabutment, Inc.
Dental · 206d
Cleared Jul 14, 2022
Examination gloves-Type A(Latex gloves)
K214017 · LYY
Jiangxi Kemei Medical Apparatus &...
General Hospital · 204d
Cleared Jul 14, 2022
CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft,...
K220040 · HCG
Medos International SARL
Neurology · 190d
Cleared Jul 14, 2022
Disposabel Syringe with permanently attached needle, Safety Syringe with...
K220204 · FMF
Anhui Tiankang Medical Technology...
General Hospital · 170d
Cleared Jul 14, 2022
20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit...
K220258 · JKA
Avia Vascular
General Hospital · 164d
Cleared Jul 14, 2022
Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and...
K220348 · OLO
Remex Medical Corporation
Orthopedic · 157d
Cleared Jul 14, 2022
Dermatac Drape
K220560 · OMP
3M
General & Plastic Surgery · 136d
Cleared Jul 14, 2022
E-GPS Navigated Instruments
K220862 · OLO
Precision Spine, Inc.
Orthopedic · 112d
Cleared Jul 14, 2022
SmileSeries
K221097 · NXC
Ordont Orthodontic Laboratories, Inc.
Dental · 91d
Cleared Jul 14, 2022
AHI System
K221203 · QNV
Fifth Eye, Inc.
Cardiovascular · 79d