35 results · 24ms · Sources: EU EUDAMED, US FDA

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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