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
17761–17784 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 05, 2021
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and...
K202076 · LZA
Shen Wei (Usa), Inc.
General Hospital · 221d
Cleared Mar 05, 2021
Biodegradable Thermoplastic Elastomer Examination (TPE) Glove
K202078 · LZA
Shen Wei (Usa), Inc.
General Hospital · 221d
Cleared Mar 05, 2021
Optellum Virtual Nodule Clinic, Optellum software, Optellum platform
K202300 · POK
Optellum, Ltd.
Radiology · 204d
Cleared Mar 05, 2021
Vivid E80/ Vivid E90/ Vivid E95
K202658 · IYN
GE Medical Systems Ultrasound and...
Radiology · 172d
Cleared Mar 05, 2021
NeoWave Pain Relief and Recovery System, Model# T16-2020
K202693 · IRP
Eva Medtec, Inc.
Physical Medicine · 171d
Cleared Mar 05, 2021
Andorate Universal Endoscope Tip Guard
K202838 · OCU
Ga Health Company Limited
Gastroenterology & Urology · 161d
Cleared Mar 05, 2021
NeuroCap (Model DEC22)
K202913 · GXY
Memory MD, Inc.
Neurology · 157d
Cleared Mar 05, 2021
FlexSys
K203054 · GEX
Gme (German Medical Engineering) GmbH
General & Plastic Surgery · 149d
Cleared Mar 05, 2021
Akesis Galaxy RTi
K203146 · IWB
Akesis, Inc.
Radiology · 135d
Cleared Mar 05, 2021
Reprocessed Inquiry Steerable Diagnostic EP Catheter
K203261 · DRF
Innovative Health, LLC
Cardiovascular · 120d
Cleared Mar 05, 2021
OEC 3D
K203346 · OXO
Ge Oec Medical Systems, Inc.
Radiology · 112d
Cleared Mar 05, 2021
Surgical Mask
K203425 · FXX
Bdc Dental Corporation , Ltd.
General Hospital · 105d
Cleared Mar 05, 2021
Cios Select (VA21) Flat Panel
K210309 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Mar 05, 2021
SafeSept Blunt Needle
K210328 · DRC
Pressure Products Medical Device...
Cardiovascular · 29d
Cleared Mar 04, 2021
Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor,...
K202018 · BZQ
Hill-Rom, Inc.
Anesthesiology · 226d
Cleared Mar 04, 2021
Disposable medical mask
K202137 · FXX
U-Play Products Corporation
General Hospital · 216d
Cleared Mar 04, 2021
BD Intraosseous Infusion System
K203193 · MHC
Bard Access Systems,...
General Hospital · 127d
Cleared Mar 04, 2021
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
K203323 · LNH
Canon Medical Systems Corporation
Radiology · 112d
Cleared Mar 04, 2021
AlignRT Plus
K203387 · IYE
Vision Rt, Ltd.
Radiology · 106d
Cleared Mar 04, 2021
MI DeTACH
K210006 · DXC
Biorep Technologies, Inc.
Cardiovascular · 59d
Cleared Mar 04, 2021
Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module...
K210019 · CCK
Unimed Medical Supplies, Inc.
Anesthesiology · 59d
Cleared Mar 04, 2021
Surgical Face Mask
K210225 · FXX
Feng Chun Yuan Medical Equipment...
General Hospital · 35d
Cleared Mar 04, 2021
Cios Select (VA21) Image Intensifier
K210307 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Mar 04, 2021
V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161,...
K210324 · DXC
Carefusion 2200, Inc.
Cardiovascular · 28d