23 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SOPRO 281
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814732·GENUMEDI EXTRA WIDE SAND SIZE V
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814725·GENUMEDI EXTRA WIDE SAND SIZE IV
HARRIS FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896053571·HARRIS FORCEPS TUNGSTEN CARBIDE DUST RING TIP F...
K2M General Instruments
FDA UDI
VB Spine LLC·10888857520332·Split Tube Retractor, Size Ø14x50 mm
QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO:APEX MEDICAL IF-4100
FDA 510(k)
FDA Class 2
·Neurology
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 19, 2014
NI
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code NKB·May 18, 2011
MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS
FDA Adverse Event
Malfunction
·MENTOR TEXAS·Product code LCJ·October 20, 2020
MENTOR CPX 4 BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·May 24, 2022
MENTOR CPX 4 BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·June 27, 2024
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
FDA Enforcement
Class III
·Terminated·Illumina Inc·December 31, 2014
GALAXY G3 XSFT 3.5MM X 7.5CM
FDA Adverse Event
Injury
·CERENOVUS, INC.·Product code KRD·July 7, 2023
GALAXY G3 4MM X 7CM
FDA Adverse Event
Injury
·CERENOVUS, INC.·Product code KRD·July 7, 2023
GALAXY G3 XSFT 2MM X 2CM
FDA Adverse Event
Injury
·CERENOVUS, INC.·Product code KRD·July 7, 2023
MENTOR CPX 4 BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·December 9, 2022
GALAXY G3 XSFT 3.5MM X 7.5CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·June 15, 2022
GALAXY G3 XSFT 2MM X 2CM
FDA Adverse Event
Injury
·CERENOVUS, INC.·Product code KRD·July 7, 2023