10,000 results
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43ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IP-XS COMPRESSION NAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CONVERTIBLE ADAPTER 4 INCH EXTENSION
FDA Adverse Event
Injury
·ERIKA DE REYNOSA·Product code KDJ·March 16, 2001
HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORP.·Product code FKX·October 20, 1997
CONVERTIBLE ADAPTER 4 INCH EXTENSION
FDA Adverse Event
Injury
·ERIKA DE REYNOSA·Product code KDJ·March 16, 2001
MINICAP PD TRANSFER SET (EASY-LOCK) WITH TWIST CLAMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code KDJ·November 5, 1998
IPX 1
FDA Adverse Event
Injury
·RESPIRONICS·Product code BZD·June 10, 2008
CONVERTIBLE ADAPTER 4 INCH ENTENSION
FDA Adverse Event
Injury
·ERIKA DE REYNOSA·Product code KDJ·March 16, 2001
HOMECHOICE AUTOMATED PD SET W/CASSETTE 4 PRONG
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORP.·Product code FKX·June 22, 1998
MINICAP DISCONNECT CAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORP.·Product code KDJ·August 2, 2001
MEDI-TEMP
FDA Adverse Event
Malfunction
·GAYMAR INDUSTRIES, INC.·Product code KZL·December 22, 2010
MINICAP EXTENDED LIFE PD TRANSFER SET (EASY-LOCK)
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·September 30, 2004
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·March 12, 2025
Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
FDA Recall
Terminated
·Sensus Healthcare, Inc.·Product code JAD·February 10, 2023
Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
FDA Enforcement
Class II
·Terminated·Sensus Healthcare, Inc.·March 15, 2023
ECO SET 2PRONG W/2PREFILL 30/C
FDA Adverse Event
Injury
·MEDISYSTEMS·Product code KDJ·June 20, 2000
MEDFUSION 4000 SYRINGE INFUSION PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·September 19, 2023
MAYFIELD
FDA Adverse Event
Injury
·OHIO MEDICAL INSTRUMENT CO.·Product code IPX·January 26, 1993
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·October 2, 2014
MINICAP TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·November 16, 2023
EVIS EXERA III BRONCHOVIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code EOQ·February 2, 2024