3,305 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOPLATE ZIP SYSTEM
FDA Adverse Event
Other
·BIOPLATE, INC.·Product code GXN·July 17, 2009
UNK - SCREWS: ZERO-P
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code OVE·April 14, 2021
UNK - CONSTRUCTS: ZERO-P
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code OVE·April 14, 2021
UNK - CAGE/PLATE: ZERO-P
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code OVE·April 14, 2021
AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System. 320301 distributed outside the U.S. Device Description The AQUABEAM Robotic System is intended for use in patients suffering from lower urinary tract symptoms resulting from benign prostatic hyperplasia (BPH).
FDA Recall
Terminated
·PROCEPT BIOROBOTICS CORPORATION·Product code PZP·March 6, 2019
AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.
FDA Recall
Open, Classified
·PROCEPT BIOROBOTICS CORPORATION·Product code PZP·July 9, 2021
AQUABEAM ROBOTIC SYSTEM
FDA Adverse Event
Injury
·PROCEPT BIOROBOTICS CORPORATION·Product code PZP·April 30, 2021
AQUABEAM ROBOTIC SYSTEM
FDA Adverse Event
Injury
·PROCEPT BIOROBOTICS CORPORATION·Product code PZP·April 23, 2021
AQUABEAM ROBOTIC SYSTEM
FDA Adverse Event
Injury
·PROCEPT BIOROBOTICS CORPORATION·Product code PZP·April 1, 2021
AQUABEAM ROBOTIC SYSTEM
FDA Adverse Event
Malfunction
·PROCEPT BIOROBOTICS CORPORATION·Product code PZP·May 7, 2021
AQUABEAM ROBOTIC SYSTEM
FDA Adverse Event
Malfunction
·PROCEPT BIOROBOTICS CORPORATION·Product code PZP·April 12, 2021
AQUABEAM ROBOTIC SYSTEM
FDA Adverse Event
Injury
·PROCEPT BIOROBOTICS CORPORATION·Product code PZP·April 23, 2021
AQUABEAM ROBOTIC SYSTEM
FDA Adverse Event
Injury
·PROCEPT BIOROBOTICS CORPORATION·Product code PZP·May 26, 2021
AQUABEAM ROBOTIC SYSTEM
FDA Adverse Event
Injury
·PROCEPT BIOROBOTICS CORPORATION·Product code PZP·May 26, 2021
AQUABEAM ROBOTIC SYSTEM
FDA Adverse Event
Malfunction
·PROCEPT BIOROBOTICS CORPORATION·Product code PZP·May 18, 2021
AQUABEAM ROBOTIC SYSTEM
FDA Adverse Event
Injury
·PROCEPT BIOROBOTICS CORPORATION·Product code PZP·June 4, 2021
AQUABEAM ROBOTIC SYSTEM
FDA Adverse Event
Malfunction
·PROCEPT BIOROBOTICS CORPORATION·Product code PZP·April 1, 2021
AQUABEAM ROBOTIC SYSTEM
FDA Adverse Event
Injury
·PROCEPT BIOROBOTICS CORPORATION·Product code PZP·June 4, 2021
AQUABEAM ROBOTIC SYSTEM
FDA Adverse Event
Malfunction
·PROCEPT BIOROBOTICS CORPORATION·Product code PZP·April 23, 2021
AQUABEAM ROBOTIC SYSTEM
FDA Adverse Event
Injury
·PROCEPT BIOROBOTICS CORPORATION·Product code PZP·June 18, 2021