17 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODEL 2500A PALMSAT PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Batrik Brush/White/BD 5+6mm/BL 50mm
FDA UDI
Batrik Medical Manufacturing Inc·00690521007758·Brush/White/BD 5+6mm/BL 50mm/OL 50cm - Asymetri...
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659181847·T-plates, right angle _x000D_...
T-plates, right angle 56mm/4x4 holes
FDA UDI
mahe medical gmbh·EMAH00200500560·T-plates, right angle
56mm/4...
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710420500560·Anterior Lateral Wedge Osteotomy Guide, 50mm x ...
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710410500560·Anterior Closing Wedge Osteotomy Guide, 50mm x ...
PERSONA® Persona SoluTion™
FDA UDI
Zimmer, Inc.·00889024231276·
PERSONA® Persona SoluTion™
FDA UDI
Zimmer, Inc.·00889024231283·
UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·July 10, 2019
INCEPTA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·April 10, 2013
THERA-I DR
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code DXY·May 20, 2008
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 1, 2011
Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016
Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (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