Search FDA 510(k) Database

6,852 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
15481–15504 of 174,061
Cleared May 11, 2021
DART-FIRE EDGE Cannulated Screw System
K203228 · HWC
Wright Medical
Orthopedic · 190d
Cleared May 11, 2021
Neurodyn V2.0, Neurodyn Aussie V2.0
K210572 · IPF
Ibramed Equipamentos Medicos
Physical Medicine · 74d
Cleared May 11, 2021
Air Pressure Therapy System: VU-IPC06
K210967 · IRP
Xiamen Weiyou Intelligent Technology...
Physical Medicine · 41d
Cleared May 10, 2021
Solax Electric Scooter (Models: S204311M, S204161, S204143)
K190737 · INI
Dongguan Prestige Sporting Goods Co.,...
Physical Medicine · 780d
Cleared May 10, 2021
Yumizen C1200 Creatinine PAP
K193649 · JFY
HORIBA ABX SAS
Chemistry · 497d
Cleared May 10, 2021
Single-use medical poly (vinyl chloride) examination glove
K201504 · LYZ
Anhui Bytech Medical Supplies Co., Ltd.
General Hospital · 339d
Cleared May 10, 2021
ChoiceSpine Blackhawk Ti Cervical Spacer System
K203311 · OVE
Choice Spine, LLC
Orthopedic · 181d
Cleared May 10, 2021
Endo Motor
K203320 · EKX
Guilin Woodpecker Medical Instrument...
Dental · 179d
Cleared May 10, 2021
Diode Laser Therapy Systems
K210168 · GEX
Beijing Kes Biology Technology Co., Ltd.
General & Plastic Surgery · 108d
Cleared May 07, 2021
Bigfoot Unity Diabetes Management System
K202145 · QLG
Bigfoot Biomedical, Inc.
Chemistry · 280d
Cleared May 07, 2021
Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)
K203036 · LZA
Central Medicare Sdn Bhd
General Hospital · 214d
Cleared May 07, 2021
Karl Storz Radel Sterilization Trays
K203572 · KCT
KARL STORZ Endoscopy-America, Inc.
General Hospital · 151d
Cleared May 07, 2021
FuseForce™ Flex Dynamic Compression System
K203832 · JDR
Wright Medical
Orthopedic · 128d
Cleared May 07, 2021
Reprocessed Tri Pulse Compression Garment
K203847 · JOW
Renu Medical, Inc.
Cardiovascular · 127d
Cleared May 07, 2021
SURGICAL MASK, Model Name:C015
K210218 · FXX
Qingdao Hainuo Biological Engineering...
General Hospital · 100d
Cleared May 07, 2021
Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
K210366 · LZA
Onetexx Sdn Bhd
General Hospital · 88d
Cleared May 07, 2021
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)
K210755 · LZA
Meditech Gloves Sdn Bhd
General Hospital · 53d
Cleared May 06, 2021
Umbilical Vessels Catheter
K201697 · FOS
Haolang Medical USA Corporation
General Hospital · 318d
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
Talent-Pro Electromagnetic Stimulator
K202031 · IPF
Remed Co., Ltd.
Physical Medicine · 288d
Cleared May 06, 2021
KardiFlex NC Coronary Dilatation Catheter
K202578 · LOX
Medcaptain Life Science Co., Ltd.
Cardiovascular · 240d
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
DRPx Locking Distal Radius Plate System
K202971 · HRS
Orthopaedic Implant Company
Orthopedic · 218d
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