34 results
·
27ms
·
Sources: EU EUDAMED, US FDA
AlfaSight 9000 Thermographic System
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768512·GENUMEDI PSS GREEN VII
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304239784·
AGXO
FDA UDI
Oticon A/S·05707131289025·H110V2 TI, RITE 312 WL SGR AGXO
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100134·KRATZ-BARRAQUER SPECULUM LEFT EYE
Femoral Cutting Block Size 2
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215074371·
OPUS SPEEDSCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 27, 2020
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 15, 2015
MPACT FLAT PE HC LINER Ø36/F
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·February 19, 2018
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code LZG·February 10, 2017
X-SUIT NIR COVERED BILIARY METALLIC STENT
FDA Adverse Event
Malfunction
·MEDINOL LTD.·Product code FGE·December 27, 2017
OSS-K 17CM DIAPH SEG SMOOTH
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·July 30, 2024
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 6, 2013
SYNCHRON LX20 PRO SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JGS·June 8, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·September 5, 2008
FREEDOM CONSTR HD 36MM T1 STD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWZ·December 6, 2021
FREEDOM ALL POLY CUP 58MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWZ·December 6, 2021
ARCOMXL 32MM RLC LNR MROM SZ23
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·June 18, 2018