15 results
·
19ms
·
Sources: EU EUDAMED, US FDA
DOUBLE CLOSED URINARY DRAINAGE SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PROFILE 750 BLOOD CELL COUNTER
FDA 510(k)
FDA Class 2
·Hematology
SIMPLER MINI IMPLANT, MODELS SM 5002, SM 5003, SM 5004
FDA 510(k)
FDA Class 2
·Dental
LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 11X360MM X 1
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code JDS·October 11, 2012
ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·May 23, 2014
OPTICROSS?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code OBJ·June 19, 2014
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·October 22, 2010
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·November 15, 2012
PDS TAPE VIO 60CM 10MM
FDA Adverse Event
Injury
·ETHICON INC.·Product code NHB·April 23, 2020
HARMONIC ACE 5MM SHEAR
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·August 16, 2019
ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN)
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·April 22, 2020
UNKNOWN CONTOUR CURVED CUTTER STAPLER
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 22, 2020
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·April 22, 2020
PROXIMATE*75MM LINEAR CUTTER
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 22, 2020
Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021