32 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CoRoent
FDA UDI
Nuvasive, Inc.·00887517578716·CoRoent Ant TLIF Ti, 13x10x32mm 0°
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780382874·Integra® Jarit® Stille-Liston Bone Cutting Forc...
PROFILE
FDA UDI
Medos International Sàrl·10886705010431·PROFILE CANNULATED INTERFERENCE SCREW ROUND HEA...
NA
FDA UDI
Stryker GmbH·34546540229817·CANCELLOUS BONE SCREWS, CROSS-PIN
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365118890·
WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW
FDA 510(k)
FDA Class 2
·Cardiovascular
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·May 2, 2023
SURESTEP
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CGA·May 9, 2000
X SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·October 21, 2014
UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CGA·September 1, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 16, 2013
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Recall
Open, Classified
·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025
VANGUARD COMPLETE KNEE FEMUR RIGHT 60MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·February 27, 2025
HORIZONTAL/VERTICAL LUMBAR VALVE (50-80, 230-320)
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES IMPLANTS S.A.·Product code JXG·May 14, 2004
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Enforcement
Class II
·Ongoing·Abbott Point Of Care Inc.·September 24, 2025
H/V LUMBAR VALVE SYSTEM WHITE, (50-80, 230-320)
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES IMPLANTS S.A.·Product code JXG·January 13, 2004
H/V LUMBAR VALVE SYSTEM WHITE, (50-80, 230-320)
FDA Adverse Event
Other
·INTEGRA NEUROSCIENCES IMPLANTS S.A.·Product code JXG·November 13, 2008
H/V LUMBAR VALVE SYSTEM WHITE, (50-80, 230-320)
FDA Adverse Event
Injury
·INTEGRA NEUROSCIENCES IMPLANTS S.A.·Product code JXG·August 2, 2007