23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SONON Ultrasound Imaging System, Model: SONON 500L
FDA 510(k)
FDA Class 2
·Radiology
Closed Suction Catheters
FDA UDI
Ningbo Xinwell Medical Technology Co., Ltd.·06971944910295·Closed Suction Catheters
Mepilex® Up
FDA UDI
Mölnlycke Health Care AB·07333350779269·Mepilex Up 20x20cm
G185
FDA UDI
RESEARCH INSTRUMENTS LIMITED·05060554120086·G185 Incubator for assisted reproduction
G185
FDA UDI
RESEARCH INSTRUMENTS LIMITED·05060554120093·Incubator for Assisted reproduction
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702439311·Elvarex Forte 3/Thigh High/Slant-Closed Toe-Ele...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702827279·ELVAREX 3/KNEE HIGH/SLANT-CLOSED TOE-ELEPHANTIA...
BP® Lordotic
FDA UDI
ZIMMER SPINE, INC.·00889024338609·
NA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295087854·VENT TUBES
GORE® EXCLUDER® AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·April 4, 2014
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523101252·R CR Cemented Femoral Component Sz 4
Statcorp Medical
FDA UDI
Statcorp Medical·10841522104749·BP CUFF,TL NEO NON-PVC,1T,SZ 2,4-8CM,M316
CARDIOX FLOW DETECTION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SMARTSHEARS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·July 27, 2020
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·July 25, 2019
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 30, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 15, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 9, 2013
Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].
FDA Recall
Terminated
·CooperSurgical, Inc.·Product code FMZ·June 30, 2021