FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
6553–6576 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 2024
HIGHERDOSE Red and Infrared Light Mask (MK66-L)
K241933 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 87d
Cleared Sep 27, 2024
TearRepair Liquid Skin Protectant
K241916 · KMF
Optmed, Inc.
General & Plastic Surgery · 88d
Cleared Sep 27, 2024
Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential,...
K241909 · LZA
O&M Halyard, Inc.
General Hospital · 88d
Cleared Sep 27, 2024
trophon Wireless Ultrasound Probe Holder
K241536 · OUJ
Nanosonics Limited
General Hospital · 120d
Cleared Sep 27, 2024
Sourcerer
K241513 · OLX
Brain Electrophysiology Laboratory...
Neurology · 121d
Cleared Sep 27, 2024
JBS-LVO
K241480 · QAS
JLK, Inc.
Radiology · 126d
Cleared Sep 27, 2024
iCare ST500 (TA04)
K241447 · HKY
Icare Finland OY
Ophthalmic · 128d
Cleared Sep 27, 2024
encevis (2.1)
K240993 · OMB
Ait Austrian Institute of Technology...
Neurology · 169d
Cleared Sep 27, 2024
ID Free Personal Lubricant
K240745 · NUC
Westridge Laboratories, Inc.
Obstetrics & Gynecology · 192d
Cleared Sep 27, 2024
CAC (gated) Algorithm
K240369 · JAK
BunkerHill Health
Radiology · 233d
Cleared Sep 27, 2024
Aulisa Temperature Module (TM0002)
K240220 · FLL
Taiwan Aulisa Medical Devices...
General Hospital · 245d
Cleared Sep 27, 2024
Hudson RCI® Comfort Flo Nasal Cannula
K240163 · BTT
Medline Industries, LP
Anesthesiology · 249d
Cleared Sep 27, 2024
AMC Health CareConsole
K233446 · MWI
Amc Health
Cardiovascular · 344d
Cleared Sep 26, 2024
Verifine® Pen Needles
K242632 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 23d
Cleared Sep 26, 2024
Cannulated PsiFGuard
K241895 · SCY
Spineguard
Orthopedic · 90d
Cleared Sep 26, 2024
Microwave Ablation Generator (KY-2000A, KY-2100A)
K241827 · NEY
Canyon Medical, Inc.
General & Plastic Surgery · 94d
Cleared Sep 26, 2024
Protean Fragment Plating System
K241815 · HRS
Skeletal Dynamics, Inc.
Orthopedic · 94d
Cleared Sep 26, 2024
Affixus Tibial and Antegrade Femoral Nailing System
K241651 · HSB
Zimmer, Inc.
Orthopedic · 111d
Cleared Sep 26, 2024
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W,...
K241414 · DXF
Circa Scientific, Inc.
Cardiovascular · 132d
Cleared Sep 26, 2024
cryo-GO Vitrification Device
K241341 · MQK
Fujifilm Irvine Scientific
Obstetrics & Gynecology · 136d
Cleared Sep 26, 2024
myAir
K241216 · BZD
ResMed Corp
Anesthesiology · 148d
Cleared Sep 26, 2024
Any-Com
K241147 · EBF
Mediclus Co., Ltd.
Dental · 154d
Cleared Sep 26, 2024
BioButton System
K241101 · DRG
Biointellisense, Inc.
Cardiovascular · 157d
Cleared Sep 26, 2024
Permatage Settable Bone Putty
K241027 · GXP
Orthocon, Inc.
Neurology · 164d