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
19825–19848 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 18, 2020
DePuy ATTUNE™ Total Knee System
K201347 · OIY
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Jun 17, 2020
LT Antibacterial Alginate with Silver Dressing
K192478 · FRO
Zhejiang Longterm Medical Technology...
General & Plastic Surgery · 281d
Cleared Jun 17, 2020
Yxoss CBR®
K192747 · JEY
Reoss GmbH
Dental · 261d
Cleared Jun 17, 2020
Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503
K193253 · FLL
Shenzhen Changkun Technology Co., Ltd.
General Hospital · 212d
Cleared Jun 17, 2020
AI-Rad Companion Brain MR
K193290 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 203d
Cleared Jun 17, 2020
Miru 1day UpSide (midafilcon A)
K193399 · LPL
Menicon Co, Ltd.
Ophthalmic · 194d
Cleared Jun 17, 2020
INOmax DSIR Plus
K200389 · MRN
Mallinckrodt Manufacturing, LLC
Anesthesiology · 120d
Cleared Jun 17, 2020
ArtiSential Laparoscopic Instruments - Electrodes
K200875 · GEI
Livsmed, Inc.
General & Plastic Surgery · 77d
Cleared Jun 17, 2020
qER
K200921 · QAS
Qure.Ai Technologies
Radiology · 72d
Cleared Jun 17, 2020
Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System
K201029 · KWQ
Spinal Elements, Inc.
Orthopedic · 58d
Cleared Jun 17, 2020
Aerus Medical Guardian,model F170A
K201220 · FRA
Aerus Medical, LLC
General Hospital · 42d
Cleared Jun 17, 2020
Medline UNITE Jones Fracture Screw System
K201319 · HWC
Medline Industires, Inc.
Orthopedic · 30d
Cleared Jun 17, 2020
Entuit Nasal Jejunal Feeding Tube
K201322 · KNT
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 30d
Cleared Jun 16, 2020
Spinal Fixation System
K190408 · NKB
Shangdong Kangsheng Medical Devices...
Orthopedic · 481d
Cleared Jun 16, 2020
Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil,...
K192542 · GEI
Modern Medical Equipment...
General & Plastic Surgery · 274d
Cleared Jun 16, 2020
Koya Ripple
K193288 · JOW
Koya, Inc.
Cardiovascular · 202d
Cleared Jun 16, 2020
TRUMATCH Personalized Solutions
K193540 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 179d
Cleared CT Jun 16, 2020
Control-IQ Technology
K200467 · QJI
Tandem Diabetes Care, Inc.
Chemistry · 111d
Cleared Jun 16, 2020
iTotal® Identity Posterior Stabilized Knee Replacement System
K201023 · JWH
Conformis, Inc.
Orthopedic · 57d
Cleared Jun 15, 2020
Visalis V500, Visalis S500
K193376 · HQC
Carl Zeiss Meditec, AG
Ophthalmic · 193d
Cleared Jun 15, 2020
F3D Cervical Stand-Alone Interbody Fusion System
K200087 · OVE
Corelink, LLC
Orthopedic · 152d
Cleared Jun 15, 2020
Pump In Style
K200508 · HGX
Medela, LLC
Obstetrics & Gynecology · 105d
Cleared Jun 15, 2020
Quantib AI Node
K200899 · LLZ
Quantib B.V.
Radiology · 73d
Cleared Jun 15, 2020
Abiomed 23 Fr Sheath
K201116 · DYB
Abiomed, Inc.
Cardiovascular · 49d