11 results · 29ms · Sources: EU EUDAMED, US FDA

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Stiletto Extended Dwell Catheter

FDA 510(k)
FDA Class 2 ·General Hospital

Best Seal

FDA UDI
BEST SEAL SURGICAL DRAPES·00869319000268·Litho Drape w/ separate UBD

INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST

FDA 510(k)
FDA Unclassified ·Unknown

VERTICOR K-WIRE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

ZENIX

FDA UDI
Zoll Medical Corporation·00198843000322·ZENIX, HOSPITAL MID LEVEL + VENTILATION, CONFIG...

HEARTSTART MRX

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code LDD·October 21, 2008

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011

ENDOTAK RELIANCE

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVY·July 8, 2013

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