17 results
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19ms
·
Sources: EU EUDAMED, US FDA
COULTER ALP (ALK PHOS) REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SureStep™ Foley Tray System Bardex® Lubricath® Temperature Sensing Catheter
FDA UDI
C. R. Bard, Inc.·00801741120978·SureStep™ Foley Tray System Bardex® Lubricath® ...
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526785007·EPICOMED ELBOW SUPPORT SILVER VI
3M™ Unitek™
FDA UDI
3M COMPANY·30605861027619·3M™ Unitek™ Stainless Steel Second Primary Mola...
Bard® Criticore® Foley Tray with Bardex® Lubricath® Temp Sensing Catheter
FDA UDI
C. R. Bard, Inc.·00801741019296·Bard® Criticore® Foley Tray with Bardex® Lubric...
Ring Curette
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896120075·Ring Curette Sharp
Intervertebral Body Fusion Device
FDA UDI
PRECISION SPINE, INC.·00840019922968·Paddle 16mm
COLLAGEN DENTAL MEMBRANE IV
FDA 510(k)
FDA Class 2
·Dental
PSK ENDOSCOPE CLEANING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LINER: MPACT FLAT PE HC LINER 32/C
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·July 26, 2021
HUDSON CONCHA NEPTUNE
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTT·May 1, 2014
U BY KOTEX CLICK
FDA Adverse Event
Malfunction
·AVENT S. DE R.L. DE C.V.·Product code HEB·January 7, 2013
ULTRAPRO MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·November 10, 2010
BALL HEADS: MECTACER BIOLOX OPTION Ø 32
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 21, 2020
SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300916A, A301216, A301216A, A303314A, A303316A, A303318A, A303414A, A303416A, A303418A, A304400A, A304714A, A304716A, A304718A, A304914, A304916, A304918, A307414A, A307416A, A319414AM, A319416A, A319416AM, A319418AM, A319514AM, A319516A, A319516AM, A333100A, A333416A, A339414AM, A339516AM, A339516AM, A344916, A800064, A800065, A800364, A800365, A800366, A900216, A900416, A901216, A902114, A902216, A902414, A902416, A902418, A902616, A902914, A902916, A902918, A903314A, A903316A, A903318A, A903416A, A904100, A904400A, A909116M, A909216M, A919416AM, A919516AM, A942206, A942208, A942210, A942212, A942214, A942216, A942218, A942616, A942618, A943214, A943216, A943218, MTA902416 Product Usage catheter
FDA Recall
Terminated
·Bard Medical Division·Product code MJC·December 13, 2018
SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300916A, A301216, A301216A, A303314A, A303316A, A303318A, A303414A, A303416A, A303418A, A304400A, A304714A, A304716A, A304718A, A304914, A304916, A304918, A307414A, A307416A, A319414AM, A319416A, A319416AM, A319418AM, A319514AM, A319516A, A319516AM, A333100A, A333416A, A339414AM, A339516AM, A339516AM, A344916, A800064, A800065, A800364, A800365, A800366, A900216, A900416, A901216, A902114, A902216, A902414, A902416, A902418, A902616, A902914, A902916, A902918, A903314A, A903316A, A903318A, A903416A, A904100, A904400A, A909116M, A909216M, A919416AM, A919516AM, A942206, A942208, A942210, A942212, A942214, A942216, A942218, A942616, A942618, A943214, A943216, A943218, MTA902416 Product Usage catheter
FDA Enforcement
Class II
·Terminated·Bard Medical Division·February 13, 2019
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013