19 results · 22ms · Sources: EU EUDAMED, US FDA

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Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo

FDA 510(k)
FDA Class 2 ·General Hospital

Memory Vessel Probe 14cm 2.0mm nitinol wire, yellow alu handle

FDA UDI
Geister Medizintechnik GmbH·04057034046142·Memory Vessel Probe 14cm 2.0mm nitino...

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319706275·Cottle Periostial Elevator 6-1/4" (16cm), sligh...

INFX-8000V WITH

FDA 510(k)
FDA Class 2 ·Radiology

SPLINE DENTAL IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

Widex

FDA UDI
Widex A/S·05706069691320·Widex BEYOND B-F2 (Titan grey ) 110, Telecoil, ...

INDIGO SYSTEM ASPIRATION CATHETER 7D

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code QEW·August 3, 2022

INDIGO SYSTEM ASPIRATION CATHETER 7D

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code QEW·August 20, 2022

PROXIMATE RELOADABLE LINEAR STAPLER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GDW·October 22, 2008

UNKNOWN ACCOLADE (127 DEG) SIZE 3.5

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·August 3, 2011

INCEPTA

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013

INDIGO SYSTEM SEPARATOR 7D

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code QEW·September 13, 2022

INDIGO SYSTEM ASPIRATION CATHETER 7D

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code QEW·October 13, 2023

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

paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024