18 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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WATER JEL FIRE BLANKET
FDA 510(k)
FDA Class 1
·General Hospital
SureStep™ Foley Tray System Bard® Lubricath® Foley Catheter Tray
FDA UDI
C. R. Bard, Inc.·00801741104428·SureStep® Foley Tray System
Bard Lubricath Fole...
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950022489·AWL MANDIBULAR #18 5-3/4" 14.5CM
BaseVac
FDA UDI
R. E. Morrison Equipment Inc·D13028000640·1SUR4.25 | 4.5 User Simplex Surgical Vacuum | N...
0800,APS0,08,N,CLW
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828152785·0800,APS0,08,N,CLW
Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite
FDA Pre-Market Approval
FDA Class 3
·BIOFLOW(TM)
UNISTIK 3 COMFORT
FDA Adverse Event
Injury
·OWEN MUMFORD LIMITED·Product code FMK·September 28, 2018
UNISTIK 3 COMFORT
FDA Adverse Event
Malfunction
·OWEN MUMFORD LIMITED·Product code FMK·October 8, 2018
FLAATZ 750
FDA 510(k)
FDA Class 2
·Radiology
OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft
FDA 510(k)
FDA Class 2
·Orthopedic
UNISTIK 3 COMFORT
FDA Adverse Event
Injury
·OWEN MUMFORD LIMITED·Product code FMK·September 28, 2018
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·May 8, 2014
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code LZG·October 17, 2012
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 11, 2010
VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
FDA Enforcement
Class II
·Ongoing·Merge Healthcare, Inc.·March 26, 2025
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
Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025