65 results
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64ms
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Sources: EU EUDAMED, US FDA
INTENSIVE THERAPEUTICS, INC.
FDA registration
INTENSIVE THERAPEUTICS, INC.·1 product·🇺🇸 United States
ABBOTT SL2 SHEATH
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code DYB·March 10, 2025
IMPELLA
FDA Adverse Event
Injury
·ABIOMED, INC. - 1220648·Product code OZD·April 2, 2026
IMPELLA
FDA Adverse Event
Injury
·ABIOMED, INC. - 1220648·Product code OZD·March 11, 2026
PULSE GEN MODEL 1000
FDA Adverse Event
Injury
·LIVANOVA USA, INC.·Product code LYJ·December 30, 2025
IMPELLA
FDA Adverse Event
Injury
·ABIOMED, INC. - 1220648·Product code OZD·April 17, 2026
CITADEL PATIENT CARE SYSTEM
FDA Adverse Event
Injury
·ARJOHUNTLEIGH POLSKA·Product code FNL·January 9, 2018
IMPELLA
FDA Adverse Event
Injury
·ABIOMED, INC. - 1220648·Product code OZD·March 11, 2026
IMPELLA
FDA Adverse Event
Injury
·ABIOMED, INC. - 1220648·Product code OZD·February 23, 2026
LUCAS (T) CPR CHEST COMPRESSION SYSTEM
FDA Adverse Event
Death
·JOLIFE AB·Product code DRM·July 1, 2014
HEARTWARE VENTRICULAR ASSIST SYSTEM-PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·June 14, 2018
REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION
FDA Adverse Event
Death
·MILLYARD ADVANCED MEDICAL PRODUCTS, LLC·Product code QJY·February 19, 2026
HEARTWARE VENTRICULAR ASSIST SYSTEM-PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·April 5, 2018
HEARTWARE VENTRICULAR ASSIST SYSTEM-PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·January 11, 2019
Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Biocardia, Inc.·April 2, 2014
Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Biocardia, Inc.·April 2, 2014
MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic: BioCardia Inc. San Carlos, CA 94070 Intended to provide a pathway through which medical instruments such as balloon dilation catheters, guidewires and other therapeutic devices may be introduced into the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Biocardia, Inc.·February 26, 2014
Titan XL Handpiece Infrared Therapeutic Heating Lamp, Manufactured by Cutera Inc, Brisbane, CA Infrared therapeutic heating lamp, intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness.
FDA Recall
Terminated
·Cutera Inc·Product code ILY·May 8, 2010
Mistique Infusion Catheter, K12-MIC13510, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010
Mistique Infusion Catheter, K12-MIC09005, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010