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
20929–20952 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 31, 2020
Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia
K192535 · EIH
Qinhuangdao Audental Metal Technology...
Dental · 137d
Cleared Jan 31, 2020
Tamper Evident Cap
K193192 · FMF
International Medical Industries, Inc.
General Hospital · 73d
Cleared Jan 31, 2020
ACUSON Sequoia Diagnostic Ultrasound System
K193257 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 66d
Cleared Jan 31, 2020
ProLift Expandable System
K193258 · MAX
Life Spine, Inc.
Orthopedic · 66d
Cleared Jan 31, 2020
CapLOX II®/TowerLOX® MIS Pedicle Screw System
K193270 · NKB
Captiva Spine, Inc.
Orthopedic · 66d
Cleared Jan 31, 2020
Physica LMC Knee System
K193284 · JWH
Lima Corporate S.P.A.
Orthopedic · 65d
Cleared Jan 31, 2020
BIOEASY Multi-Drug Test Cup
K193480 · NGL
Shenzhen Bioeasy Biotechnology Co., Ltd.
Toxicology · 46d
Cleared Jan 31, 2020
HAD1717MC
K200018 · MQB
H&Abyz
Radiology · 28d
Cleared Jan 30, 2020
Linshom Respiratory Monitoring Device (LRMD)
K190734 · BZQ
Linshom Management, LLC
Anesthesiology · 315d
Cleared Jan 30, 2020
SCS 17-01
K190956 · MQV
Anika Therapeutics, Inc.
Orthopedic · 294d
Cleared Jan 30, 2020
EndoClot
K191254 · PLL
Endoclot Plus Co., Ltd.
Gastroenterology & Urology · 265d
Cleared Jan 30, 2020
TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord
K192339 · KNS
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 155d
Cleared Jan 30, 2020
TruDi Navigation System
K192397 · PGW
Biosense Webster
Ear, Nose, Throat · 149d
Cleared Jan 30, 2020
Neo
K192889 · OMA
Eemagine Medical Imaging Solutions GmbH
Neurology · 112d
Cleared Jan 30, 2020
HySil Super Fast Impression Materials
K192941 · ELW
Osstem Implant Co., Ltd.
Dental · 104d
Cleared Jan 30, 2020
ATTUNE All-Polyethylene Tibia
K193057 · JWH
Depuy Ireland UC
Orthopedic · 90d
Cleared Jan 30, 2020
Noritake Super Porcelain EX-3
K193060 · EIH
Kuraray Noritake Dental, Inc.
Dental · 90d
Cleared Jan 30, 2020
GTK Veress Needles
K193339 · HIF
Guangzhou T.K Medical Instrument Co.,...
Obstetrics & Gynecology · 59d
Cleared Jan 29, 2020
TruAbutment DS
K183106 · NHA
Truabutment, Inc.
Dental · 447d
Cleared Jan 29, 2020
Carescape B850
K191323 · MHX
GE Healthcare Finland Oy
Cardiovascular · 259d
Cleared Jan 29, 2020
Quantum® Total Ankle Prosthesis
K191380 · HSN
In2bones Sas
Orthopedic · 251d
Cleared Jan 29, 2020
Biopsy Needle
K191472 · FCG
Ushare Medical, Inc.
General & Plastic Surgery · 240d
Cleared Jan 29, 2020
Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc,...
K191498 · LJE
Cook Incorporated
Gastroenterology & Urology · 238d
Cleared Jan 29, 2020
MectaTap TI Suture Anchor
K191677 · MBI
Medacta International S.A.
Orthopedic · 219d