Search FDA 510(k) Devices

5,474 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2021–2021 ×
3,023 results
2017–2040 of 3,023
Cleared May 06, 2021
Identity Imprint Knee Replacement System
K210191 · JWH
Conformis, Inc.
Orthopedic · 101d
Cleared May 06, 2021
ImagePilot
K210066 · LLZ
Konica Minolta, Inc.
Radiology · 115d
Cleared May 06, 2021
CoolSeal Reveal
K203640 · GEI
Bolder Surgical, LLC
General & Plastic Surgery · 143d
Cleared May 06, 2021
CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)
K203183 · GEI
Bolder Surgical, LLC
General & Plastic Surgery · 191d
Cleared May 06, 2021
DRPx Locking Distal Radius Plate System
K202971 · HRS
Orthopaedic Implant Company
Orthopedic · 218d
Cleared May 06, 2021
3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties...
K202598 · FXX
3A Medical Products Co., Ltd.
General Hospital · 240d
Cleared May 06, 2021
KardiFlex NC Coronary Dilatation Catheter
K202578 · LOX
Medcaptain Life Science Co., Ltd.
Cardiovascular · 240d
Cleared May 06, 2021
Talent-Pro Electromagnetic Stimulator
K202031 · IPF
Remed Co., Ltd.
Physical Medicine · 288d
Cleared May 06, 2021
SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL
K201936 · KPE
Gilero, LLC
General Hospital · 297d
Cleared May 06, 2021
Umbilical Vessels Catheter
K201697 · FOS
Haolang Medical USA Corporation
General Hospital · 318d
Cleared May 05, 2021
OIC External Fixation System
K211112 · KTT
Orthopaedic Implant Company
Orthopedic · 21d
Cleared May 05, 2021
Bose SoundControl Hearing Aids
K211008 · QDD
Bose Corporation
Ear, Nose, Throat · 30d
Cleared May 05, 2021
OrthoGold 100
K210451 · ISA
Tissue Regeneration Technologies, LLC
Physical Medicine · 78d
Cleared May 05, 2021
GR-14 Resin System
K210298 · EBI
Pro3dure Medical GmbH
Dental · 91d
Cleared May 05, 2021
D function
K203525 · NUW
Ito Co., Ltd.
Dental · 155d
Cleared May 05, 2021
Genius / Genuin Total Knee System
K200765 · JWH
Biorad Medisys Pvt, Ltd.
Orthopedic · 407d
Cleared May 04, 2021
SOTA Cloud Imaging
K210682 · LLZ
Sota Precision Optics, Inc. Dba Sota...
Radiology · 57d
Cleared May 04, 2021
Quantum Mini Ventilation Module
K210669 · DTX
Spectrum Medical , Ltd.
Cardiovascular · 60d
Cleared May 04, 2021
Surgical Mask
K210304 · FXX
Jin Pin Electrical Co., Ltd. Zhuhai...
General Hospital · 90d
Cleared May 04, 2021
CoLink Sfx Implant System
K203698 · HTY
In2bones USA, LLC
Orthopedic · 137d
Cleared May 04, 2021
Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed...
K203655 · NLH
Innovative Health, LLC
Cardiovascular · 140d
Cleared May 04, 2021
VASSALLO GT Hybrid
K203529 · DQX
Filmecc Co., Ltd.
Cardiovascular · 153d
Cleared May 04, 2021
EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)
K203450 · EOX
Capnostics, LLC
Gastroenterology & Urology · 162d
Cleared May 04, 2021
CaP Spheres Pellet Pack
K203218 · MQV
Zimmer Biomet Spine, Inc.
Orthopedic · 183d