9 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sim&Size
FDA 510(k)
FDA Class 2
·Radiology
LCP
FDA UDI
Synthes GmbH·10886982168146·4.5MM LCP® PROXIMAL FEMUR HOOK PLATE 10 HOLES/2...
AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM
FDA 510(k)
FDA Class 1
·Dental
DENFIL
FDA 510(k)
FDA Class 2
·Dental
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 2, 2023
CADENCE
FDA Adverse Event
Injury
·RESPIRONICS CALIFORNIA, INC.·Product code BTO·November 25, 2008
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 9, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2013
33CM DORSEY GRASPER FORCEPS, P/N 0250080319. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014