21 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO MARSPO2, MODEL 2001
FDA 510(k)
FDA Class 2
·Cardiovascular
CUSTOM PROCEDURE KIT
FDA UDI
MEDIVATORS INC.·40677964006720·The ENDO CARRY-ON Procedure Kit contains all of...
PowerPICC
FDA UDI
Bard Access Systems, Inc.·00801741144769·Catheter Placement Kit
TruLock
FDA UDI
Rmo, Inc.·00885797658289·TRULOCK Light Activated Adhesive Kit (4ea Syrin...
LIFENET Adapter 32-BIT
FDA UDI
PHYSIO-CONTROL, INC.·00883873903438·LIFENET Adapter 32-BIT RELEASE 5.3.3
DIGITAL INFLECTION RIGIDOMETER (DIR)
FDA 510(k)
FDA Unclassified
·Unknown
MODIFICATION TO CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWP·June 16, 2011
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·June 2, 2017
UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code KTT·August 22, 2023
UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code KTT·August 22, 2023
UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KTT·August 22, 2023
UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KTT·August 14, 2023
UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code KTT·August 22, 2023
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·March 12, 2013
COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 24, 2011
ACHALASIA PNEUMATIC HAND PUMP AND MONITOR
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code GBA·February 21, 2008
Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KTT·August 22, 2023
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025