22 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890105911·Zirlux Implant Analog
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964151316·Endo Carry-on Procedure Kit contains Basin, VIA...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450129210·
Faulhaber Pinzetten KG
FDA registration
Faulhaber Pinzetten KG·33 products·🇩🇪 Germany
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345027961·Lumbar Inserter, PLIF, 7-10H
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0105010·Implant Inserter, 11-13mm, Sleeved
DIMENSION PENTA H, DIMENSION PENTA H QUICK
FDA 510(k)
FDA Class 2
·Dental
EEG WITH VIDEO, MODEL EX-NW
FDA 510(k)
FDA Class 2
·Neurology
TRUSTEEL
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·May 26, 2025
TRUSTEEL
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·June 5, 2025
GMK-SPHERE 02.12.0312FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 29, 2021
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·March 15, 2013
NC QUANTUM APEX PTCA DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·March 8, 2011
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008
BLUNT TIP SCREW, 4X42MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·October 1, 2020
BLUNT TIP SCREW, 4X38MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·October 1, 2020
INFLOW TUBING FMS VUE 24PK
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code HRX·March 7, 2025
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
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024