31 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ADVANCED GLASS IONOMER (K-130) RESTORATIVE
FDA 510(k)
FDA Class 2
·Dental
Medline Industries, Inc.
FDA UDI
MEDLINE INDUSTRIES, INC.·10193489206272·ENHANCED ISOLATION KIT SM-LG
Sklar®
FDA UDI
SKLAR CORPORATION·10649111338090·MIXING/SOLUTION BOWL 5 QT
StarBurst
FDA UDI
NAVILYST MEDICAL, INC.·H7877001014931·RITA StarBurst Electrosurgical Device
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383556217·Gutta Percha Points is used to root canal filin...
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383501231·Gutta Percha Points is used to root canal filin...
Sklar®
FDA UDI
SKLAR CORPORATION·30649111192221·MIXING/SOLUTION BOWL 5 QT PK12
DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001
FDA 510(k)
FDA Class 1
·Dental
MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY
FDA 510(k)
FDA Class 2
·Radiology
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 2, 2013
FUJINON
FDA Adverse Event
FUJIFILM OPTICS CO., LTD. MITO FACTORY·Product code FDA·August 27, 2014
AS HUMERAL HEAD FX RIGHT 44
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSD·May 17, 2011
Torcon NB
FDA UDI
COOK INCORPORATED·00827002470484·Torcon NB Advantage Catheter
B125M Patient Monitor, REF 6160000-005-XXXXXXX
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·December 28, 2022
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Model Number L101, ESSENTIO DR SL Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Model Number U128, VALITUDE CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Model Number L210 PROPONENT SR SL Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·July 14, 2021
VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·July 14, 2021