14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CPL Insulin Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
BLT Profile Drill, short
FDA UDI
BIO CONCEPT Co., Ltd.·06947600304098·
Malibu™
FDA UDI
Seaspine Orthopedics Corporation·10889981030100·PRECONTOURED ESS ROD, 5.5 x 90 mm
Precontoured Rod Ø5.5 mm x90 mm Package
FDA UDI
XENCO MEDICAL LLC·B064XM21510901·
Ø5.5mm X 90mm PRECONTOURED RODS
FDA UDI
XENCO MEDICAL LLC·B064XMPH21510902·
EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
X-CHANGE
FDA 510(k)
FDA Class 1
·Physical Medicine
VERSAFITCUP CC PE ACETABULAR INSERT Ø 36 / F
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 11, 2015
LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·October 8, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013
ASR ACETABULAR IMPLANT 62
FDA Adverse Event
Injury
·DEPUY INTL., LTD.·Product code KWA·June 30, 2011
LIFE SCOPE G9
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·June 13, 2024
LIFE SCOPE G9
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·October 27, 2023
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 26, 2014