18 results
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24ms
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Sources: EU EUDAMED, US FDA
ULTRASOUND IMAGING SYSTEM, MODEL 7300
FDA 510(k)
FDA Class 2
·Radiology
ELEGANCE OPTICAL MANUFACTORY LTD.
FDA registration
ELEGANCE OPTICAL MANUFACTORY LTD.·3 products·🇭🇰 Hong Kong
RUSCH BRONCHUS BLOCKER KIT
FDA 510(k)
FDA Class 2
·Anesthesiology
ETEST GATIFLOXACIN
FDA 510(k)
FDA Class 2
·Microbiology
KEEPSAFE FALL MONITOR
FDA Adverse Event
Malfunction
·J. T. POSEY CO.·Product code KMI·March 12, 2013
SPRINT FIDELIS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 6, 2011
RENU (UNKNOWN TYPE)
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code LPN·May 9, 2008
PKG, GRASPER FORCEPS, DELICATE, FENESTRATED, P/N 0250080322. 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
UNK - CONSTRUCTS: 3.5 MM LCP P
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·May 12, 2026
UNK - CONSTRUCTS: NARROW LCP
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·May 12, 2026
UNK - CONSTRUCTS: NARROW LCP
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·May 12, 2026
UNK - CONSTRUCTS: 3.5 MM LCP P
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·May 12, 2026
UNK - CONSTRUCTS: LCP
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·May 12, 2026
UNK - CONSTRUCTS: 3.5 MM LCP P
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·May 12, 2026
UNK - CONSTRUCTS: 3.5 MM LCP P
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·May 12, 2026
UNK - CONSTRUCTS: LCP
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·May 12, 2026
UNK - CONSTRUCTS: 3.5 MM LCP P
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·May 12, 2026
UNK - CONSTRUCTS: 3.5 MM LCP P
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·May 12, 2026