18 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EMBRYOGEN
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197053204·Pean Hemostatic Forceps, delicate
curved...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197053198·Pean Hemostatic Forceps, delicate
curved...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197053211·Pean Hamostatic Forceps, delicate
curved...
27 G X 4 11/16 IN. BD¿ LONG LENGTH WHITACRE SPINAL NEEDLE
FDA Adverse Event
Injury
·BD CARIBE LTD.·Product code BSP·November 18, 2015
27 G X 4 11/16 IN. BD¿ LONG LENGTH WHITACRE SPINAL NEEDLE
FDA Adverse Event
Injury
·BD CARIBE LTD.·Product code BSP·November 18, 2015
27 G X 4 11/16 IN. BD¿ LONG LENGTH WHITACRE SPINAL NEEDLE
FDA Adverse Event
Injury
·BD CARIBE LTD.·Product code BSP·November 18, 2015
K140347
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 6, 2021
K140347
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 6, 2021
DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO
FDA 510(k)
FDA Class 2
·Dental
IVC SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
FREESTYLE PRECISION NEO
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·January 10, 2017
INTIMA-II Y 24GAX0.75IN MZ PRN SLM NPVC
FDA Adverse Event
Malfunction
·Product code FOZ·September 3, 2021
TRIDENT ALUMINA INSERT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MRA·October 3, 2014
MONOPOLAR CURVED SCISSORS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·May 31, 2013
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·June 15, 2011
Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressure monitoring port is a disposable medical device intended for use on patients requiring temporary augmentation of ventilation with or without supplemental oxygen delivery during episodes of acute ventilatory failure or insufficiency.
FDA Enforcement
Class I
·Terminated·Teleflex Medical·July 1, 2015
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019