30 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HYPOTHERMX INTRAVENOUS FLUID WARMER
FDA 510(k)
FDA Class 2
·General Hospital
EVOTECH™
FDA UDI
ADVANCED STERILIZATION PRODUCTS SERVICES INC.·10705037000517·Channel Connector Tube, White
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814527·GENUMEDI SAND SIZE I
Cragg-McNamara
FDA UDI
Micro Therapeutics, Inc.·00836462000087·Valved Infusion Catheter
Cragg Mc-Namara Valved Infusion Catheter
FDA UDI
Micro Therapeutics, Inc.·00763000272302·INF CATH 41038-01 CRAGG-MC V07 ATHLONE
Cragg-McNamaraTM
FDA UDI
Micro Therapeutics, Inc.·00847536006669·INF CATH 41038-01 CRAGG-MCNAMARA V04
Cragg McNamaraTM
FDA UDI
Micro Therapeutics, Inc.·00847536006652·INF CATH 41038-01 CRAGG-MCNAMARA V03
Ophthalmic Hooks
FDA UDI
KATENA PRODUCTS, INC.·00841668114308·SINSKEY IOL HOOK ANG (BX/3)
K133801
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 31, 2024
ANATOMICAL PRESS-FIT HUMERAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
ULTRASAFE DENTAL INJECTION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·May 26, 2021
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 27, 2020
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 19, 2014
PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7
FDA Adverse Event
Injury
·ARROW INTL., INC.·Product code DXE·May 24, 2011
SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 42-15
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSD·June 26, 2018
EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE
FDA Adverse Event
Malfunction
·SHIRAKAWA OLYMPUS CO., LTD.·Product code PSV·December 12, 2024
SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 50-21
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSD·June 11, 2018
Biograph mMR. Model Number: 10433372.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025