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
5953–5976 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 30, 2024
LUXEN 5G
K241151 · EIH
Dentalmax Co., Ltd.
Dental · 158d
Cleared Sep 30, 2024
YSI 2900C Biochemistry Analyzer
K210933 · CGA
Ysi, Inc.
Chemistry · 1281d
Cleared Sep 27, 2024
Optima Coil System (OptiBlock Line Extension)
K242582 · HCG
Balt USA, LLC
Neurology · 28d
Cleared Sep 27, 2024
Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150...
K242571 · NEW
Hyundae Meditech Co., Ltd.
General & Plastic Surgery · 29d
Cleared Sep 27, 2024
ClotTriever XL Catheter (41-102)
K242557 · QEW
Inari Medical, Inc.
Cardiovascular · 30d
Cleared Sep 27, 2024
AllTest Multi-Drug Urine Test Panel
K242540 · NFT
Hangzhou AllTest Biotech Co., Ltd.
Toxicology · 32d
Cleared Sep 27, 2024
Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral...
K242213 · PPN
Shockwave Medical, Inc.
Cardiovascular · 60d
Cleared Sep 27, 2024
ACTIVO
K242206 · GEX
Daeju Meditech Engineering Co., Ltd.
General & Plastic Surgery · 60d
Cleared Sep 27, 2024
Elvie Stride 2
K242125 · HGX
Chiaro Technology, Ltd.
Obstetrics & Gynecology · 70d
Cleared Sep 27, 2024
EasyCare Tx 2
K241939 · BZD
ResMed Corp
Anesthesiology · 87d
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