18 results · 21ms · Sources: EU EUDAMED, 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