Search FDA 510(k) Devices

5,413 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2021–2021 ×
3,023 results
1081–1104 of 3,023
Cleared Aug 30, 2021
VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)
K211630 · LON
bioMerieux, Inc.
Microbiology · 95d
Cleared Aug 30, 2021
Paratrooper Plantar Plate Repair System
K211322 · MBI
Paragon 28, Inc.
Orthopedic · 122d
Cleared Aug 30, 2021
Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor,...
K211041 · DXN
Shenzhen Yuezhongxing Technology Co.,...
Cardiovascular · 144d
Cleared Aug 30, 2021
Ceribell Instant EEG Headband
K210805 · GXY
Ceribell, Inc.
Neurology · 166d
Cleared Aug 30, 2021
Impulse AM Interbody Fusion System
K210090 · MAX
Degen Medical
Orthopedic · 229d
Cleared Aug 28, 2021
Nitrile Blue Powder-free Examination Glove
K211390 · LZA
Cardinal Health200, LLC
General Hospital · 115d
Cleared Aug 28, 2021
Surgical Mask
K211255 · FXX
Tianchang Kanghui Protective Products...
General Hospital · 124d
Cleared Aug 28, 2021
AnyOne External Implant System
K203554 · DZE
Megagen Implant Co., Ltd.
Dental · 267d
Cleared Aug 27, 2021
AcQMap High Resolution Imaging and Mapping System
K212345 · DQK
Acutus Medical, Inc.
Cardiovascular · 30d
Cleared Aug 27, 2021
K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage
K212038 · ODP
K&J Consulting Corporation
Orthopedic · 58d
Cleared Aug 27, 2021
Virage Navigation System
K212023 · OLO
Zimmer Biomet Spine, Inc.
Orthopedic · 59d
Cleared Aug 27, 2021
MyoSPECT, MyoSpect ES
K212004 · KPS
Ge Healthcare
Radiology · 60d
Cleared Aug 27, 2021
Sonendo Filling Material 5C
K211995 · KIF
Sonendo, Inc.
Dental · 60d
Cleared Aug 27, 2021
PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
K211684 · NEZ
Given Imaging Ltd. (Medtronic)
Gastroenterology & Urology · 87d
Cleared Aug 27, 2021
LOGIQ E10s, LOGIQ Fortis
K211524 · IYN
Ge Healthcare
Radiology · 102d
Cleared Aug 27, 2021
BEE PLIF Cage
K211413 · MAX
NGMedical GmbH
Orthopedic · 113d
Cleared Aug 27, 2021
SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM...
K211373 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 115d
Cleared Aug 27, 2021
XSTAT 30 Pouch
K210676 · PGZ
Revmedx, Inc.
General & Plastic Surgery · 175d
Cleared Aug 27, 2021
PrimeTaper EV Dental Implant
K210610 · DZE
Dentsply Sirona, Inc.
Dental · 179d
Cleared Aug 27, 2021
WOLF Thrombectomy System, 6F
K210530 · QEW
Devoro Medical, Inc.
Cardiovascular · 184d
Cleared Aug 27, 2021
Trevo NXT ProVue Retriever
K210502 · POL
Stryker Neurovascular
Neurology · 186d
Cleared Aug 27, 2021
Clear Aligners
K210373 · NXC
Shenzhen Yinuo Dental Technology Co.Ltd
Dental · 200d
Cleared Aug 27, 2021
Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)
K210122 · MAI
Osteonic Co., Ltd.
Orthopedic · 220d
Cleared Aug 27, 2021
Stiletto Extended Dwell Catheter
K210047 · PND
Piper Access, LLC
General Hospital · 231d