18 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RICHTER MALE LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526827899·ACHIMED ACHILLES SUPP BLACK I
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526827837·***DISC*LEVAMED ANKLE SUPPORT BLACK I
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704507461·
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108698848·Digital Analog from NT-TRADING WP
MODIFICATION TO ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINE WANDS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES
FDA 510(k)
FDA Class 2
·Cardiovascular
PRECISION NOVI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 1, 2020
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 17, 2020
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 6, 2020
BE-VKMO 70000 #QUADR-I HMO70000+VHK7100
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015
BE-VKMO 70000 #QUAD-I HMO70000+VHK7100
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015
BE-VKMO 70000 #QUADR-I HMO70000+VHK7100
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015
BE-VEMO 7000 #QUADR-I HMO70000+VHK7100
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 22, 2013
RESERVOIR 1.8 ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·March 29, 2011
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·July 7, 2008
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.
FDA Enforcement
Class II
·Terminated·Instrumed International, Inc.·October 8, 2014