21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MED RF 4000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036034290·
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319706299·Rollet Retractor 5-1/4" (13.3cm), 6mm wide, 4 s...
Prelude IDeal™ Hydrophilic Sheath
FDA UDI
Merit Medical Systems, Inc.·00884450532799·
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
NEUCOLONCARE
FDA 510(k)
FDA Class 2
·Radiology
Widex
FDA UDI
Widex A/S·05706069914511·WIDEX MOMENT MRB2D (Shocking pink ) 110, Teleco...
Widex
FDA UDI
Widex A/S·05706069691856·Widex BEYOND B-F2 (Shocking pink ) 110, Telecoi...
Widex
FDA UDI
Widex A/S·05706069827316·WIDEX EVOKE EBB3D (Shocking pink ) 110, Telecoi...
LANCET DEVICE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·October 29, 2014
SPECTRA OPTIA EXCHANGE SET
FDA Adverse Event
Other
·CARIDIANBCT·Product code LKN·August 1, 2011
FLEXTEND II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 8, 2013
SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX¿ System(s), UniCel¿ DxC 600/800 System(s) and Synchron¿ Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid (CSF).
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·July 3, 2013
SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX System(s), UniCel DxC 600/800 System(s) and Synchron Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid (CSF).
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code KHP·May 28, 2013
Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE
FDA Enforcement
Class I
·Ongoing·Busse Hospital Disposables, Inc.·January 10, 2024
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 19, 2023
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024