22 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NexPak X
FDA UDI
HEMOSTASIS, LLC·00858439001637·NexPak X Intranasal Splint is a sterile flexibl...
5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/65MM
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code JDP·August 28, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 26, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·March 2, 2015
MYSTIQUE® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110531101·MYSTIQUE® MB RT RX 018 U5-5/L3-3 CS HK
MYSTIQUE® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110532101·MYSTIQUE® MB RT RX 022 U 5-5/L3-3 CS HK
MYSTIQUE® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110531111·MYSTIQUE® MB RT RX 018 U 5-5/L3-3 CS-BC HK
IMPLANT, FIXATION DEVICE CONDYLAR PLATE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code JDP·February 23, 2017
CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CROSS-CHECKS DUAL, MODEL CI 125
FDA 510(k)
FDA Class 2
·General Hospital
IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code JDP·June 1, 2015
TRIXIE
FDA Adverse Event
ARJO MED AB LTD·Product code FSA·April 8, 2013
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OZO·September 23, 2014
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 1, 2011
STERNALOCK BLU SYSTEM BLADE, STERNALOCK POWERDRIVER
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·January 10, 2019
4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/RIGHT
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code HRS·July 24, 2015
Whatman Body Fluid Collection Paper- 903 California Newborn Screening Card Ref 110534 903 Card are intended for use by healthcare professionals in the collection and in-vitro storage of neonate human blood. The neonate blood is tested to screen the infant for congenital abnormalities of metabolism and other conditions.790
FDA Recall
Terminated
·Whatman, Inc.·Product code JKA·October 29, 2009
Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·August 30, 2017
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016