17 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AZUL PERSONAL LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587T14103470·14mm TLIF Implant 10mm Wide 34mm Length 7 Degrees
UniTip Catheter
FDA UDI
Unisensor AG·07640172971406·
SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NIOX MINO MODEL 09-1000
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AP409 -PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·December 18, 2025
AP205 - INFUSION SET WITH NON-VENTED SPIKE, 1.2UM FILTER AND NEEDLE Y-SITE
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·June 5, 2024
AP210 - MICROBORE WITH NON-VENTED SPIKE AND 1.2UM FILTER
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·June 6, 2024
AP210 - MICROBORE WITH NON-VENTED SPIKE AND 1.2UM FILTER
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·June 17, 2024
M.U.S.T. PEDICLE SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PML·February 26, 2026
AP403 - MICROBORE INFUSION SET WITH VENTED/NON-VENTED SPIKE
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·March 31, 2026
AP407 - INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER AND NEEDLELESS Y-SITE
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·March 4, 2026
PLATE, CURVED, 10 HOLE, UPPERFACE, STERILE
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS-FREIBURG·Product code JEY·June 3, 2013
UNKNOWN ZIMMER SHOULDER
FDA Adverse Event
Injury
·ZIMMER INC.·Product code HSD·June 21, 2011
LID F/BATT-HANDPIECE NO. 05.001.201 F/TR
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code MOQ·October 3, 2014
M.U.S.T. PEDICLE SCREW SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PML·November 13, 2025
C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·September 24, 2014