15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036028770·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450204344·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197455268·Tebbet Breast Retractor
90x27m...
SURGIC IV IMPLANT CONTROL UNIT
FDA 510(k)
FDA Class 1
·Dental
WAVESCAN WAVEFRONT SYSTEM MODEL HS 1
FDA 510(k)
FDA Class 1
·Ophthalmic
ZEPHIR® ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·April 24, 2014
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWP·February 18, 2011
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·January 3, 2017
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·September 20, 2013
PROMUS ELEMENT? PLUS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 2, 2013
SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 15, 2014
HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 16, 2011
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·October 12, 2011
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024