23 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle
FDA 510(k)
FDA Class 2
·Anesthesiology
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551111108·HALO, 1203-5 VEST PED3, LAMBSWOOL LINER, 1211-1...
Mariner Deformity
FDA UDI
Seaspine Orthopedics Corporation·10889981295103·Iliac Tap, Navigated, 8.5mm
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197306546·Hartmann ear forceps, crocodile
2x6 mm...
BD PLASTIPAK¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·August 14, 2023
GUIDEWIRE INTRODUCER SAFETY NEEDLE
FDA 510(k)
FDA Class 2
·Cardiovascular
SHARPS TANK REUSABLE SHARPS CONTAINER
FDA 510(k)
FDA Class 2
·General Hospital
PORTRAIT PSR3
FDA Adverse Event
Injury
·RHYTEC INCORPORATED·Product code GEI·October 24, 2008
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·August 5, 2011
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 8, 2013
TEOSYAL RHA 3
FDA Adverse Event
Injury
·TEOXANE SA·Product code LMH·December 20, 2022
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Injury
·COVIDIEN·Product code OUT·January 9, 2015
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Injury
·COVIDIEN·Product code OUT·January 9, 2015
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·February 20, 2026
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·January 23, 2026
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·June 25, 2025
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·January 23, 2026
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·January 29, 2026
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 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