12 results
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27ms
·
Sources: EU EUDAMED, US FDA
CENTRIFICHEM CK
FDA 510(k)
FDA Class 2
·Clinical Chemistry
0800,APS1,08,N,VL,JRW,PVKEY
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828152853·0800,APS1,08,N,VL,JRW,PVKEY
ACUMED
FDA UDI
Acumed LLC·10806378040108·Uni. Tray Olec-Cor Plate Insert Assy.
SPECTRUM
FDA UDI
Ortho Arch Company Inc·D9098001271·SPECTRUM THREE PRONG CLASP PLIER
ADP,1,P800,(2)S800,1/4",N,AUSTCO
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828118613·ADP,1,P800,(2)S800,1/4",N,AUSTCO
KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10
FDA 510(k)
FDA Class 2
·Ophthalmic
ELI 230 ELECTROCARDIOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and volume.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·December 12, 2018
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 8, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·October 12, 2012
MODULAR HEX DRIVER
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code HXX·August 10, 2010
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021