35 results
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24ms
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Sources: EU EUDAMED, US FDA
CRANIAL DRILL
FDA 510(k)
FDA Class 2
·Neurology
Preat
FDA UDI
Preat Corporation·00842092183731·ASC Zimmer? TSV-compatible 3.5mm X 9mm Non-Enga...
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964002173·The ENDO CARRY-ON Procedure Kit contains all of...
GC Fuji II LC®
FDA UDI
Gc America Inc.·D0470001951·GC Fuji II LC® A1, 15 g powder btl.
GC Fuji II LC®
FDA UDI
Gc America Inc.·14548161283281·GC Fuji II LC® A1, 15 g powder btl.
Dissector
FDA UDI
ATRICURE, INC.·00818354010367·Articulating Dissection Instrument, 27 cm shaft
Dissector
FDA UDI
ATRICURE, INC.·10840143902017·Articulating Dissection Instrument, 27 cm shaft
Matrix Wearable
FDA UDI
GLOBAL INSTRUMENTATION, LLC·00815187020600·M5 Recorder, 4-Lead Patient Cable RL Lead AHA, ...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197507387·Inner Sheath
18.5Fr...
Catheter Extender for Yamato Plus IABs - 10 Pack
FDA UDI
DATASCOPE CORP.·10607567111537·Catheter Extender for Yamato Plus IABs - 10 Pack
MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM),
FDA 510(k)
FDA Class 2
·Neurology
OLYMPUS SONOSURG TROCAR XT3900 SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
VOGUE NATURAL Y LOW PROFILE SILASTIC, SIZE 10, SIZE 8
FDA Adverse Event
MEDICAL ENGINEERING CORP.·Product code FTR·December 21, 1993
HIGH PROFILE, 400 CC
FDA Adverse Event
MCGHAN MEDICAL CORP.·Product code FTR·December 21, 1993
LUX 1440
FDA Adverse Event
Malfunction
·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012
ATRICURE BIPOLAR SYSTEM
FDA Adverse Event
Death
·ATRICURE, INC.·Product code GEI·February 27, 2009
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·February 14, 2013
PRECISE PRO RX CAROTID STENT SYSTEM
FDA Adverse Event
Death
·CORDIS DE MEXICO·Product code NIM·February 24, 2011
TRIATHLON PS FEM COMPONENT, CEMENTED
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·February 19, 2008
Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG PT-000011 M/D: INT1-D001-MM UDI 10385082000009 The Omnipod DASH Personal Diabetes Manager (PDM) is a mobile, handheld Android device that is intended to communicate with the Omnipod DASH Pod (pump).
FDA Enforcement
Class II
·Terminated·Insulet Corporation·April 1, 2020