13 results
·
20ms
·
Sources: EU EUDAMED, US FDA
HANSEN MEDICAL ARTISAN S CONTROL CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036028985·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776362836·Potts Elevator,
ORTHO CONTROL FEMALE URINARY CONTROL DEVICE
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
ACCU-CHEK ADVANTAGE METER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ENDOLOOP LIGATURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GEA·December 27, 2018
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·December 27, 2018
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·January 9, 2014
GORILLA/BABY GORILLA PLATING SYSTEM
FDA Adverse Event
Injury
·PARAGON 28, INC·Product code HRS·September 17, 2020
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 2, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 15, 2014
ONYX AVM
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code MFE·May 16, 2011
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024