13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODES MDL. 2
FDA 510(k)
FDA Class 2
·Physical Medicine
ENDO-SCRUB®
FDA UDI
MEDTRONIC XOMED, INC.·20681490050900·SHEATH 1912014 5PK SMTH NPH ENT 4MM/30DG
PRINCETON
FDA UDI
Princeton Medical Group, Inc.·00810158218369·SCISSOR STANDARD SHARP/SHARP STRAIGHT 5.75"
PROFYLE
FDA UDI
Stryker GmbH·37613153150047·BONE SCREWS, CROSS-FIT, SELF-TAPPING
ZYSTON STRAIGHT SPACER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·January 11, 2013
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·December 1, 2010
5.0MM CANNULATED LOCKING SCREW80MM
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·July 3, 2014
O-ARM 1000 IMAGING SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·November 9, 2017
ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020
ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020
Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884; 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, UPC 818392011593; 3) SOL-M 5ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1851815B, UPC 818392011609; 4) SOL-M 10ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1811815B, UPC 818392011616;
FDA Enforcement
Class II
·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024