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
17281–17304 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 04, 2021
A-Link Z
K201671 · OVD
Acuity Surgical Devices, LLC
Orthopedic · 319d
Cleared May 04, 2021
PtoleMedic System
K202521 · LLZ
Lento Medical Innovation, Inc.
Radiology · 245d
Cleared May 04, 2021
Uro-G Cystoscope
K202921 · FAJ
Uroviu Corporation
Gastroenterology & Urology · 217d
Cleared May 04, 2021
Medline Vacu-line Suction Aspirator
K203135 · BTA
Medline Industries, Inc.
General & Plastic Surgery · 197d
Cleared May 04, 2021
NaviCam Xpress Stomach System
K203192 · QKZ
Anx Robotica Corp
Gastroenterology & Urology · 188d
Cleared May 04, 2021
CaP Spheres Pellet Pack
K203218 · MQV
Zimmer Biomet Spine, Inc.
Orthopedic · 183d
Cleared May 04, 2021
EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)
K203450 · EOX
Capnostics, LLC
Gastroenterology & Urology · 162d
Cleared May 04, 2021
VASSALLO GT Hybrid
K203529 · DQX
Filmecc Co., Ltd.
Cardiovascular · 153d
Cleared May 04, 2021
Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed...
K203655 · NLH
Innovative Health, LLC
Cardiovascular · 140d
Cleared May 04, 2021
CoLink Sfx Implant System
K203698 · HTY
In2bones USA, LLC
Orthopedic · 137d
Cleared May 04, 2021
Surgical Mask
K210304 · FXX
Jin Pin Electrical Co., Ltd. Zhuhai...
General Hospital · 90d
Cleared May 04, 2021
Quantum Mini Ventilation Module
K210669 · DTX
Spectrum Medical , Ltd.
Cardiovascular · 60d
Cleared May 04, 2021
SOTA Cloud Imaging
K210682 · LLZ
Sota Precision Optics, Inc. Dba Sota...
Radiology · 57d
Cleared May 03, 2021
MC3 Crescent Jugular Dual Lumen Catheter
K203409 · PZS
Mc3, Inc.
Cardiovascular · 165d
Cleared May 03, 2021
Storz Medical MAGNETOLITH Muscle Stimulator
K203710 · IPF
Storz Medical AG
Physical Medicine · 133d
Cleared May 03, 2021
Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable
K203749 · CBI
Ambu A/S
Anesthesiology · 131d
Cleared May 03, 2021
EasyWhip
K210675 · GAT
Winter Innovations, Inc.
General & Plastic Surgery · 59d
Cleared May 02, 2021
Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life...
K201949 · KOI
Nihon Kohden Corporation
Anesthesiology · 293d
Cleared May 02, 2021
Kerecis Reconstruct
K202430 · OXH
Kerecis Limited
General & Plastic Surgery · 250d
Cleared Apr 30, 2021
Disposable Ureteral Access Sheath
K203165 · FED
Suzhou Beyo Medical Technology Co., Ltd.
Gastroenterology & Urology · 189d
Cleared Apr 30, 2021
The BioBrace Implant
K203267 · OWW
Biorez, Inc.
General & Plastic Surgery · 176d
Cleared Apr 30, 2021
ArtiSential Laparoscopic Instruments-Electrodes
K203580 · GEI
Livsmed, Inc.
General & Plastic Surgery · 144d
Cleared Apr 30, 2021
Innova Nasal Non-Vented Mask
K203601 · BZD
Sleepnet Corporation
Anesthesiology · 142d
Cleared Apr 30, 2021
syngo. CT Extended Functionalities
K203699 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 133d