43 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
FDA 510(k)
FDA Class 1
·General Hospital
Femoral Cutting Block Posterior Capture
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215041137·
POLYMER COATED POWDER-FREE GREY COLOR POLYCHLOROPRENE PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ABC CERVICAL PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GALAXY G3 XSFT 3.5MM X 7.5CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 2, 2022
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 8, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 19, 2014
TERUMO PERFUSION SYSTEM 8000
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code JOR·May 13, 2011
GALAXY G3 MINI 1MM X 3CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 2, 2022
GALAXY G3 MINI 1MM X 2CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 2, 2022
GALAXY G3 MINI 2MM X 6CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 2, 2022
GALAXY G3 XSFT 3MM X 6CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 2, 2022
GALAXY G3 MINI 1.5MM X 3CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 2, 2022
8.5MM MEDULLARY REAMER HEAD
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTO·August 6, 2020
GALAXY G3 MINI 1.5MM X 3CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 2, 2022
GALAXY G3 5MM X 15CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·November 2, 2022
SOMATOM Confidence -Computed tomography systems Model 10590100
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022
Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015
TherMax Blood Warmer Unit
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·November 6, 2019
HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·June 12, 2024