35 results
·
46ms
·
Sources: EU EUDAMED, US FDA
SRC Medical, Inc.
Manufacturer
🇺🇸 United States
SRC MEDICAL, INC.
FDA registration
SRC MEDICAL, INC.·2 products·🇺🇸 United States
BD VACUTAINER® MICROBIOLOGY C&S TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·May 18, 2018
BD VACUTAINER® URINE COLLECTION CUP
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JTW·June 6, 2018
NELLCOR
FDA Adverse Event
Malfunction
·MEDIANA CO. LTD.·Product code DQA·February 28, 2019
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
6060A
FDA UDI
ARC MEDICAL INC.·00850015328053·
6120A
FDA UDI
ARC MEDICAL INC.·00850015328008·
6126A
FDA UDI
ARC MEDICAL INC.·00850015328015·
7056A
FDA UDI
ARC MEDICAL INC.·00850015328039·
6070A
FDA UDI
ARC MEDICAL INC.·00850015328060·
6000A
FDA UDI
ARC MEDICAL INC.·00850015328046·
6130A
FDA UDI
ARC MEDICAL INC.·00850015328022·
Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator
FDA Enforcement
Class II
·Terminated·Cardio Medical Products·July 17, 2013
THERMOFLO FILTER PORT
FDA Adverse Event
Injury
·ARC MEDICAL, INC.·Product code JOJ·December 5, 2003
THERMOFLO FILTER
FDA Adverse Event
Death
·ARC MEDICAL, INC.·Product code DTR·January 28, 1992
THERMOFLO NEO
FDA Adverse Event
Malfunction
·ARC MEDICAL, INC.·Product code BYD·August 6, 2012
HME THERMOFLO INLINE NEO
FDA Adverse Event
Malfunction
·ARC MEDICAL INC·Product code BYD·July 2, 2012
THERMOFLO 1/2 HCH MEDIA
FDA Adverse Event
Death
·ARC MEDICAL INC.·Product code BYD·August 22, 2001
Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0.28 and 11.0.34, Reference/FSCA Identifier: CP-09798; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc. Oncology Systems·December 26, 2012