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

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SonarMed AirWave, Airway Monitoring System

FDA 510(k)
FDA Class 2 ·Anesthesiology

EBERLE

FDA UDI
Eberle GmbH & Co. KG·04050052016227·Full Radius Resector 4,2-15°gebogen

QCT Pro Asynchronous Calibration Module, CliniQCT

FDA UDI
MINDWAYS SOFTWARE, INC.·B052DIASYNC0·The QCT Pro Asynchronous Calibration Module is ...

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K1430220·Rod Cutter, Table Top

CADD

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FPA·November 23, 2021

ATMOS E 201 THORAX AND ATMOS S 201 THORAX

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052

FDA 510(k)
FDA Class 2 ·Dental

SENOMARK BREAST BIOPSY MARKER

FDA Adverse Event
Injury ·BARD PERIPHERAL VASCULAR, INC.·Product code NEU·May 23, 2013

PARASIGM REAL TIME REVEL INSULIN INFUISON PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·September 27, 2014

HILL-ROM NURSE CALL DATABASE SERVERS

FDA Adverse Event
Malfunction ·HILL-ROM·Product code ILQ·June 14, 2011

CHROMID STREPTO B AGAR

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code PQZ·November 1, 2017

CHROMID STREPTO B AGAR

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code PQZ·November 1, 2017

Hospira RECEPTAL LINERS: 1L(1000mL), 1.5L (1500mL), 2L (2000mL) 1) List Number 43056-01; 2) List Number 43023-01; 3) List Number 43025-01; 4) List Number 43025-11; 5) List Number 43025-21; 6) List Number 43025-25; 7) List Number 43038-05; 8) List Number 43043-01; 9) List Number 43044-01; 10) List Number 43044-11; 11) List Number 43046-01; 12) List Number 43047-01; 13) List Number 43041-01; 14) List Number 43024-01; 15) List Number 43027-01; 16) List Number 43027-14; 17) List Number 43001-01; 18) List Number 43064-01; 19) List Number 43046-05; 20) List Number 43042-11; 21) List Number 43042-01; 22) List Number 43044-05; 23) List Number 43044-15

FDA Enforcement
Class II ·Terminated·Hospira Inc.·August 24, 2016