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

Filters: Cleared only ×
175,820 results
27433–27456 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 2017
Modulift Vertebral Body Replacement (VBR) System
K172032 · PLR
Aesculap Implants Systems, Inc.
Orthopedic · 138d
Cleared Nov 20, 2017
Tyece OTC EMS System, Model EM35
K172241 · NGX
Tyece , Ltd.
Physical Medicine · 117d
Cleared Nov 20, 2017
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip...
K172557 · DTK
William Cook Europe Aps
Cardiovascular · 88d
Cleared Nov 20, 2017
ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue...
K172580 · GEI
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 84d
Cleared Nov 20, 2017
Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip...
K172584 · DTK
William Cook Europe Aps
Cardiovascular · 84d
Cleared Nov 20, 2017
Materialise PKA Guide System
K172650 · HSX
Materialise NV
Orthopedic · 76d
Cleared Nov 20, 2017
Stryker Self-Punching ICONIX
K172921 · MBI
Stryker
Orthopedic · 56d
Cleared Nov 20, 2017
Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator...
K172984 · DTZ
Medtronic, Inc.
Cardiovascular · 54d
Cleared Nov 20, 2017
MDR17 Mobile Direct Radiographic System
K173018 · IZL
Del Medical, Inc.
Radiology · 53d
Cleared Nov 20, 2017
Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
K173044 · DXQ
Ningbo Albert Novosino Co., Ltd.
Cardiovascular · 53d
Cleared Nov 20, 2017
Rapid Family
K173169 · GEX
Sharplight Technologies, Ltd.
General & Plastic Surgery · 52d
Cleared Nov 20, 2017
syngo®.via protoNeo (Version VA20)
K173378 · LLZ
Siemens Healthcare GmbH
Radiology · 21d
Cleared Nov 17, 2017
Langston dual lumen catheter
K170544 · DQO
Vascular Solutions, Inc.
Cardiovascular · 266d
Cleared Nov 17, 2017
CMS600P2 B-Ultrasound Diagnostic System
K170856 · IYO
Contec Medical Systems Co.,Ltd
Radiology · 240d
Cleared Nov 17, 2017
Masimo Root Monitoring System and Accessories
K171121 · MWI
Masimo Corporation
Cardiovascular · 214d
Cleared Nov 17, 2017
Single Use Electrosurgical knife
K171158 · KNS
Olympus Medical Systems Corp.
Gastroenterology & Urology · 211d
Cleared Nov 17, 2017
DIGITAL RADIOGRAPHY CXDI-410C WIRELESS
K171270 · MQB
Canon, Inc.
Radiology · 200d
Cleared Nov 17, 2017
AEON Endoscopic Stapler
K171589 · GDW
Lexington Medical, Inc.
General & Plastic Surgery · 170d
Cleared Nov 17, 2017
N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC...
K171742 · DFH
Siemens Healthcare Diagnostics...
Immunology · 158d
Cleared Nov 17, 2017
Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free...
K171743 · LZA
Smart Glove Corporation Sdn. Bhd.
General Hospital · 158d
Cleared Nov 17, 2017
Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port,...
K171961 · CBP
Xiamen Compower Medical Tech. Co., Ltd.
Anesthesiology · 140d
Cleared Nov 17, 2017
SleepRight ProRx Custom Dental Guard
K172223 · OBR
Splintek, Inc.
Dental · 116d
Cleared Nov 17, 2017
Endoform Silver Dermal Template
K172318 · FRO
Aroa Biosurgery
General & Plastic Surgery · 108d
Cleared Nov 17, 2017
DEKA SMARTXIDE TOUCH
K172362 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 105d