115 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Checkpoint, Checkpoint Head & Neck
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
MIRABAY
FDA UDI
Mirabay Orthodontics Corp.·05061075022361·KLEOS PSL METAL ROTH 022 UL1 PK5
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481119163·LOCATOR R-Tx Abutment For 3.0mm Platform Legacy...
TMA - Archwire
FDA UDI
ORMCO CORPORATION·00889989029420·ARCH TMA REV.CURVE UPR 19X025 PK/10
Batrik Arc Wire Brushes Reusable
FDA UDI
Batrik Medical Manufacturing Inc·00690521008434·Brush/White/BD 5mm/BL 50mm/OL 45cm - Rigid - RE...
Verify™ Verify Syringe/Stopcock
FDA UDI
Merit Medical Systems, Inc.·00884450410493·
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481129421·LOCATOR R-Tx Abutment, 3.0mm Internal Hex, Impl...
atrik Arc Wire Brushes Single Use
FDA UDI
Batrik Medical Manufacturing Inc·00690521008441·Brush/White/BD 5mm/BL 50mm/OL 45cm - Rigid - SI...
INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD PEN NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
VWING VASCULAR NEEDLE GUIDE
FDA Adverse Event
Injury
·VITAL ACCESS CORP.·Product code PFH·March 24, 2016
N/A
FDA UDI
Zimmer, Inc.·00889024033580·
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·BLAZER OPEN-IRRIGATED ABLATION CATHETER
BD INSULIN PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015
SEPTOJECT XL
FDA Adverse Event
Injury
·Product code DZM·July 5, 2021
UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·July 5, 2011
UNKNOWN DEPUY BROACH
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LXH·June 6, 2013
MULTI-LINK RX VISION CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·August 27, 2008
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Blazer Open-Irrigated Ablation Catheter
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Blazer Open Irrigated Temperature Ablation Catheter