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
28849–28872 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 12, 2017
1417WGC_127um and 1417WGC_140um
K171417 · MQB
Rayence Co., Ltd.
Radiology · 28d
Cleared Jun 12, 2017
1417WCC_127um and1417WCC_140um
K171418 · MQB
Rayence Co., Ltd.
Radiology · 28d
Cleared Jun 12, 2017
SonoSite X-Porte Ultrasound System
K171437 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 27d
Cleared Jun 12, 2017
Iliad® Pedicle Screw System and Zenius® Pedicle Screw System
K171509 · NKB
Medyssey USA, Inc.
Orthopedic · 20d
Cleared Jun 09, 2017
CompuFlo Epidural Computer Controlled Anesthesia System
K161883 · FMF
Milestone Scientific, Inc.
General Hospital · 333d
Cleared Jun 09, 2017
YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES...
K162569 · NUC
Biotech Lubricants, Ltd.
Obstetrics & Gynecology · 267d
Cleared Jun 09, 2017
2-Piece Hammertoe Correction System
K162685 · HWC
Life Spine, Inc.
Orthopedic · 256d
Cleared Jun 09, 2017
ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal...
K163313 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 198d
Cleared CT Jun 09, 2017
iVue
K163475 · OBO
Optovue, Inc.
Ophthalmic · 179d
Cleared Jun 09, 2017
ePlex Respiratory Pathogen Panel
K163636 · OCC
Genmark Diagnostics, Incorporated
Microbiology · 169d
Cleared Jun 09, 2017
ePlex Instrument
K163652 · NSU
Genmark Diagnostics, Incorporated
Microbiology · 168d
Cleared Jun 09, 2017
PRECICE Intramedullary Limb Lengthening System
K170169 · HSB
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 141d
Cleared Jun 09, 2017
Sterile Nitrile Surgical Gloves, Powder-free
K170515 · KGO
Primus Gloves Pvt Limited
General Hospital · 108d
Cleared Jun 09, 2017
JAZZ System, including JAZZ Band
K170730 · OWI
Implanet, S.A.
Orthopedic · 92d
Cleared Jun 09, 2017
syngo Application Software
K170747 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 91d
Cleared Jun 09, 2017
Cardinal Health Non-Reinforced Surgical Gown
K170762 · FYA
Cardinal Health200, LLC
General Hospital · 88d
Cleared Jun 09, 2017
Diamondback 360 Peripheral Orbital Atherectomy System
K170792 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 85d
Cleared Jun 09, 2017
Wingman 14C Crossing Catheter
K170996 · DQY
Reflow Medical, Inc.
Cardiovascular · 67d
Cleared Jun 09, 2017
1717SGC_127um and 1717SGC_140um
K171419 · MQB
Rayence Co., Ltd.
Radiology · 25d
Cleared Jun 09, 2017
1717SCC_127um and 1717SCC_140um
K171420 · MQB
Rayence Co., Ltd.
Radiology · 25d
Cleared Jun 08, 2017
SYNTEC HUMERAL NAIL SYSTEM
K161327 · HSB
Syntec Scientific Corporation
Orthopedic · 392d
Cleared Jun 08, 2017
NEXA Negative Pressure Wound Therapy System
K162610 · OMP
Nexa Medical , Ltd.
General & Plastic Surgery · 262d
Cleared Jun 08, 2017
Vibrance Pelvic Trainer
K162689 · HIR
Bioinfinity (M) Sdn. Bhd.
Gastroenterology & Urology · 254d
Cleared Jun 08, 2017
INVISIKNOT Ankle Syndesmosis Repair Kit
K162996 · HTN
Smith & Nephew, Inc.
Orthopedic · 224d