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
12745–12768 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 14, 2022
KDF Zirconia Disc
K221429 · EIH
Denken-Highdental Co., Ltd.
Dental · 59d
Cleared Jul 14, 2022
TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming...
K221431 · HIS
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 58d
Cleared Jul 14, 2022
Normatec Go
K221666 · IRP
NormaTec Industries, LP
Physical Medicine · 36d
Cleared Jul 13, 2022
SNUCONE Bone Level Implant System
K210354 · DZE
Snucone Co., Ltd.
Dental · 520d
Cleared Jul 13, 2022
truSculpt iD
K221407 · GEI
Cutera, Inc.
General & Plastic Surgery · 58d
Cleared Jul 13, 2022
17HQ701G-B
K221434 · MQB
Lg Electronics.Inc
Radiology · 57d
Cleared Jul 13, 2022
syngo.CT Extended Functionality
K221727 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Jul 12, 2022
Veuron-Brain-mN1
K203279 · LNH
Heuron Co., Ltd.
Radiology · 613d
Cleared Jul 12, 2022
Hemoclip
K213143 · PKL
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 288d
Cleared Jul 12, 2022
Nitrile Vinyl Blend Powder Free Examination Gloves (Black)
K213574 · LZA
Grand Work Plastic Products Co., Ltd.
General Hospital · 244d
Cleared Jul 12, 2022
N Series Patient Monitors
K213799 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 218d