Search FDA 510(k) Database

6,455 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
8425–8448 of 174,061
Cleared Aug 09, 2023
Zimmer® Natural Nail® System Cephalomedullary Nails
K231114 · HSB
Zimmer Switzerland Manufacturing GmbH
Orthopedic · 112d
Cleared Aug 09, 2023
Polyisoprene Surgical Gloves
K230304 · KGO
Puyang Linshi Medical Supplies Co., Ltd.
General Hospital · 187d
Cleared Aug 09, 2023
Air Smart Extra Spirometer
K222443 · BZG
Feellife Health, Inc.
Anesthesiology · 362d
Cleared Aug 08, 2023
Efai Pacs Picture Archiving and Communication System Pro
K232100 · LLZ
Ever Fortune.Ai, Co., Ltd.
Radiology · 25d
Cleared Aug 08, 2023
Ceribell Instant EEG Headband
K232052 · GXY
Ceribell, Inc.
Neurology · 29d
Cleared Aug 08, 2023
Disposable Medical Examination Nitrile Gloves
K232008 · LZA
Raxwell Industrial, LLC
General Hospital · 33d
Cleared Aug 08, 2023
Arthrex TightRope II
K231857 · MBI
Arthrex, Inc.
Orthopedic · 46d
Cleared Aug 08, 2023
Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter
K230620 · DQO
Gentuity, LLC
Cardiovascular · 155d
Cleared Aug 08, 2023
Visual-ICE Cryoablation System
K230551 · GEH
Boston Scientific Corporation
Orthopedic · 161d
Cleared Aug 08, 2023
LW Implant System
K223924 · DZE
Ossvis Co., Ltd.
Dental · 221d
Cleared Aug 08, 2023
Rubicon™ Control Support Catheter (H749394323506A1)
K223633 · DQY
Boston Scientific Corporation
Cardiovascular · 246d
Cleared Aug 08, 2023
Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
K222439 · LEH
Siemens Healthcare Diagnostics, Inc.
Toxicology · 361d
Cleared Aug 08, 2023
Protective Gown AAMI Level 4
K222128 · QPC
Kenpax International Limited
General Hospital · 386d
Cleared Aug 07, 2023
PRO-LITE Sterilization Tray
K231501 · KCT
STERIS Corporation
General Hospital · 75d
Cleared Aug 07, 2023
Vis-U-All Low Temperature Sterilization Pouches
K231500 · FRG
STERIS Corporation
General Hospital · 75d
Cleared Aug 07, 2023
Celerity 20 HP Biological Indicator
K231490 · FRC
STERIS Corporation
General Hospital · 76d
Cleared Aug 07, 2023
Celerity™ HP Chemical Indicator
K231488 · JOJ
Steris
General Hospital · 76d
Cleared Aug 07, 2023
LineSider® Spinal System
K231098 · NKB
Integrity Implants, Inc.
Orthopedic · 111d
Cleared Aug 07, 2023
Reprocessed Agilis NxT Steerable Introducer
K230376 · PNE
Innovative Health, LLC
Cardiovascular · 175d
Cleared Aug 07, 2023
Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy...
K223713 · LZA
Better Care Plastic Technology Co., Ltd.
General Hospital · 238d
Cleared Aug 07, 2023
V-PRO maX 2 Low Temperature Sterilization System
K223476 · MLR
STERIS Corporation
General Hospital · 262d
Cleared Aug 07, 2023
SQA-iO Sperm Quality Analyzer
K220828 · POV
Medical Electronic Systems , Ltd.
Hematology · 503d
Cleared Aug 05, 2023
Stryker Resorbable Fixation System
K230733 · JEY
Stryker Leibinger GmbH & Co KG
Dental · 142d
Cleared Aug 04, 2023
iTEMPSHIELD
K232010 · FLL
Aion Biosystems, Inc.
General Hospital · 29d