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
16345–16368 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 27, 2021
SOLOPASS System
K203251 · HAW
Intravent Medical Partners, LP
Neurology · 296d
Cleared Aug 27, 2021
ENFit Reusable Enteral Syringe
K203613 · PNR
Shantou Wealy Medical Instrument Co.,Ltd
Gastroenterology & Urology · 260d
Cleared Aug 27, 2021
RBknee
K203696 · LLZ
Radiobotics Aps
Radiology · 252d
Cleared Aug 27, 2021
Stiletto Extended Dwell Catheter
K210047 · PND
Piper Access, LLC
General Hospital · 231d
Cleared Aug 27, 2021
Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)
K210122 · MAI
Osteonic Co., Ltd.
Orthopedic · 220d
Cleared Aug 27, 2021
Clear Aligners
K210373 · NXC
Shenzhen Yinuo Dental Technology Co.Ltd
Dental · 200d
Cleared Aug 27, 2021
Trevo NXT ProVue Retriever
K210502 · POL
Stryker Neurovascular
Neurology · 186d
Cleared Aug 27, 2021
WOLF Thrombectomy System, 6F
K210530 · QEW
Devoro Medical, Inc.
Cardiovascular · 184d
Cleared Aug 27, 2021
PrimeTaper EV Dental Implant
K210610 · DZE
Dentsply Sirona, Inc.
Dental · 179d
Cleared Aug 27, 2021
XSTAT 30 Pouch
K210676 · PGZ
Revmedx, Inc.
General & Plastic Surgery · 175d
Cleared Aug 27, 2021
SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM...
K211373 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 115d
Cleared Aug 27, 2021
BEE PLIF Cage
K211413 · MAX
NGMedical GmbH
Orthopedic · 113d
Cleared Aug 27, 2021
LOGIQ E10s, LOGIQ Fortis
K211524 · IYN
Ge Healthcare
Radiology · 102d
Cleared Aug 27, 2021
PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
K211684 · NEZ
Given Imaging Ltd. (Medtronic)
Gastroenterology & Urology · 87d
Cleared Aug 27, 2021
Sonendo Filling Material 5C
K211995 · KIF
Sonendo, Inc.
Dental · 60d
Cleared Aug 27, 2021
MyoSPECT, MyoSpect ES
K212004 · KPS
Ge Healthcare
Radiology · 60d
Cleared Aug 27, 2021
Virage Navigation System
K212023 · OLO
Zimmer Biomet Spine, Inc.
Orthopedic · 59d
Cleared Aug 27, 2021
K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage
K212038 · ODP
K&J Consulting Corporation
Orthopedic · 58d
Cleared Aug 27, 2021
AcQMap High Resolution Imaging and Mapping System
K212345 · DQK
Acutus Medical, Inc.
Cardiovascular · 30d
Cleared Aug 26, 2021
Aptiva Celiac Disease IgG Reagent
K200230 · MVM
Inova Diagnostics, Inc.
Immunology · 574d
Cleared CT Aug 26, 2021
Visby Medical Sexual Health
K200748 · QEP
Visby Medical
Microbiology · 521d
Cleared Aug 26, 2021
TT Electric Breast Pump, TT Double Electric Breast Pump
K202802 · HGX
Wuxi Xinzhongrui Baby Supplies Co., Ltd.
Obstetrics & Gynecology · 337d
Cleared Aug 26, 2021
The iMask Child's Face Mask
K202831 · OXZ
Pac-Dent, Inc.
General Hospital · 335d
Cleared Aug 26, 2021
Amber Mill Q Series & Amber Mill Direct Series
K202952 · EIH
Hass Corp.
Dental · 330d