25 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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PERCUTANEOUS INTRODUCER, MODEL 10383-XXX
FDA 510(k)
FDA Class 2
·Cardiovascular
TruLock
FDA UDI
Rmo, Inc.·00885797648013·TRULOCK Primer Activated Adhesive Mini Kit (1ea...
TruLock
FDA UDI
Rmo, Inc.·00885797644930·TRULOCK Primer Activated Adhesive Kit (40 Capsule)
TASMIN R 0°
FDA UDI
SIGNUS Medizintechnik GmbH·04047844014226·The basic shape of the TASMIN R devices is a ho...
AtriClip® PRO Gillinov-Cosgrove LAA Exclusion System
FDA UDI
ATRICURE, INC.·10840143912023·LAA Exclusion System, PRO135
AtriClip™ LAA Exclusion System
FDA UDI
ATRICURE, INC.·10840143906947·AtriClip® PRO Gillinov-Cosgrove LAA Exclusion S...
AtriClip™ LAA Exclusion System
FDA UDI
ATRICURE, INC.·10840143901379·AtriClip® PRO Gillinov-Cosgrove LAA Exclusion S...
AtriClip™ LAA Exclusion System
FDA UDI
ATRICURE, INC.·00818354011784·AtriClip® PRO Gillinov-Cosgrove LAA Exclusion S...
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·January 23, 2026
LIFENET Mobile Gateway
FDA UDI
PHYSIO-CONTROL, INC.·00883873889749·LIFENET Mobile Gateway RELEASE 5.3.3
FLUROPERM 60-OK, PARAGON HDS-OK
FDA 510(k)
FDA Class 2
·Ophthalmic
SENSATION -VACUUM ASSIST DEVICES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VANGUARD PFR FEMORAL LT SM
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code KRR·May 17, 2018
10.7F PACKAGED ACCUTROL CATHETER
FDA UDI
Zoll Circulation, Inc.·00849111075404·The InnerCool Accutrol® Catheter contains an in...
Trulink
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522110757·CABLE,ECG,24 INCH 3-LW,305CM/10 FT,AAMI
STANDARD INSERTION HANDLE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code LXH·March 12, 2013
V.A.C. THERAPY SYSTEM
FDA Adverse Event
Injury
·KCI USA, INC.·Product code OMP·February 17, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·February 19, 2008
Spacelabs Medical Integrated ECG Cable are supplied as part of the start-up kits provided with some Spacelabs' monitors. The kit PNs are: 718-0017-10, 718-0017-11, 718-0017-12, and 718-0017-13. The cables are also offered as replacement parts under Spacelabs PNs: 700-0008-22, 700-0008-23, 700-0008-24, and 700-0008-25. The Spacelabs elance Vital Signs Monitor is a prescription device intended to be used by healthcare professionals in all areas of healthcare.
FDA Recall
Terminated
·Spacelabs Healthcare, Incorporated·Product code MHX·July 23, 2009
Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.
FDA Enforcement
Class II
·Terminated·Myolyn Inc.·August 24, 2022