30 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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CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964069925·Endo Carry-On Procedure Kit
Oticon
FDA UDI
Oticon A/S·05707131160089·SAFARI 300, BTE 13 P DBL
Endeavour™ TruColor™ XL
FDA UDI
METREX RESEARCH, LLC·00810210820356·Endeavour™ TruColor™ XL headlight system - Nort...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450279489·
Sklar®
FDA UDI
SKLAR CORPORATION·10649111005626·PERF PAN 12 3/4 X10 3/8 X2 1/2
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964084621·The ENDO CARRY-ON Procedure Kit contains all of...
Drill Stopper for Long L10 1852
FDA UDI
ADIN DENTAL IMPLANT SYSTEMS LTD·07290105157553·
DIMENSION HAIC ASSAY, MODEL DF105
FDA 510(k)
FDA Class 2
·Hematology
PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
LINEAR? ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 14, 2025
Drill Stopper for Long L15/Short L10 1852
FDA UDI
ADIN DENTAL IMPLANT SYSTEMS LTD·07290105157584·
ACCELSTIM
FDA Adverse Event
Injury
·ORTHOFIX·Product code LOF·June 5, 2023
VERSAFITCUP DM CEMENTLESS ACETABULAR SHELL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 12, 2013
ENSEAL TRIO
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GEI·May 6, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 19, 2014
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 10, 2011
Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2015
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 L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025