99 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FDF·September 25, 2023
PG&E Wilderness Tactical - Trauma Bag
FDA UDI
Certified Safety Manufacturing, Inc.·00766588233178·PG&E Wilderness Tactical - Trauma Bag
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167310123317200·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167310123317060·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167310123317120·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197381475·CERA-CUT® Baby-Metzenbaum Scissors
curved...
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167310123317160·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197042352·CERA-CUT® Baby-Metzenbaum Scissors
curved...
RESUSCITATION UNIT 105
FDA 510(k)
FDA Class 2
·Anesthesiology
METHADONE ENZYME IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code MAH·June 20, 2016
AEQUALIS FRACTURE IMPLANT UNKNOWN
FDA Adverse Event
Injury
·TORNIER INC.·Product code KWS·February 21, 2013
AEQUALIS FRACTURE IMPLANT UNKNOWN
FDA Adverse Event
Injury
·TORNIER INC.·Product code KWS·February 21, 2013
AEQUALIS FRACTURE IMPLANT UNKNOWN
FDA Adverse Event
Injury
·TORNIER INC·Product code KWS·February 21, 2013
AEQUALIS FRACTURE IMPLANT UNKNOWN
FDA Adverse Event
Injury
·TORNIER INC·Product code KWS·February 21, 2013
AEQUALIS FRACTURE IMPLANT UNKNOWN
FDA Adverse Event
Injury
·TORNIER INC·Product code KWS·February 21, 2013
AEQUALIS FRACTURE IMPLANT UNKNOWN
FDA Adverse Event
Injury
·TORNIER INC·Product code KWS·February 21, 2013
AEQUALIS FRACTURE IMPLANT UNKNOWN
FDA Adverse Event
Injury
·TORNIER INC·Product code KWS·February 21, 2013