146 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SHARP COLLECTION SYSTEM-SHARP-A-GATOR
FDA 510(k)
FDA Class 2
·General Hospital
DEL MAR AVIONICS 509 NEUROCORDER AMBUL
FDA 510(k)
FDA Class 2
·Cardiovascular
DIALYSIS ADMIN. SET - I.V.
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MARTIN UTERINE
FDA Adverse Event
Other
·ANCHOR PRODUCTS CO.·Product code GCJ·May 7, 2014
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·November 12, 2012
DURACON CNSTR TIB INS SML 9MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·September 20, 2010
ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Squeeze Flush, Macrodrip (Pole Mount), REF: 42640-06, Sterile EO
FDA Recall
Terminated
·ICU Medical, Inc.·Product code DRS·November 27, 2018
ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Intraflo Flush, Macrodrip (Pole Mount), REF: 42641-06, Sterile EO
FDA Recall
Terminated
·ICU Medical, Inc.·Product code DRS·November 27, 2018
ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 152 cm (60") Tubing, Disposable Transducer, 03 ml Squeeze Flush Device, Macrodrip (Pole Mount), REF: 01C-42640-06, Sterile EO
FDA Recall
Terminated
·ICU Medical, Inc.·Product code DRS·November 27, 2018
Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 1197
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FRN·October 22, 2024
REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron Filter, 3 Clamps (Blue, Yellow, White), Rotating Luer - Product Usage: The intravascular administration set is a single use, sterile, non-pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle catheter (which is inserted into a vein). Directions for Use: icumedical IV Extension Sets Clave/MicroClave/NanoClave Connectors Antimicrobial Clave/MicroClave Connectors Spiros Closed Male Luer.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code FMG·July 1, 2020
ICU Medical Plum Solos, Item number 400011001; infusion pump
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FRN·April 22, 2025
ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FRN·April 22, 2025
Plum 360/A+ spare batteries. Item Number: SUB0000864.
FDA Recall
Open, Classified
·ICU Medical Inc·Product code FRN·May 7, 2024
Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
FDA Recall
Terminated
·ICU Medical Inc·Product code FRN·August 1, 2018
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FRN·December 15, 2025
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FRN·December 15, 2025
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FRN·December 15, 2025
26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FJK·August 31, 2020
Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FMF·August 31, 2020