22 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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QXMEDICAL ACCESS & SUPPORT CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ArgenPMMA 95x25-C2
FDA UDI
ARGEN CORPORATION, THE·D818123311·Crown And Bridge, Temporary, Resin
On Call Plus Glucose Control Solution Kit
FDA UDI
Acon Laboratories, Inc.·00682607535316·Glucose Control Solution Kit includes 2mL Contr...
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167310123311200·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167310123311120·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167310123311160·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167310123311060·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197042321·CERA-CUT® Kaye Facelift Scissors
curved...
U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LOOP MICROWAVE ABLATION PROBE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970614·
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013
NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 9MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·September 26, 2014
PIN COLLET
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code GET·June 8, 2011
SENSITHERM PROBE
FDA Adverse Event
Injury
·FIAB S.P.A.·Product code FLL·July 10, 2023
TOSOH ST AIA 25-OH VITAMIN D PRETREATMENT SET
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code MRG·April 19, 2018
GMK-HINGE FEMORAL COMPONENT SIZE 2 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·June 28, 2019
GMK-HINGE FIXED TIBIAL INSERT SIZE 1/26MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·July 12, 2019
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
AlignRT Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.
FDA Recall
Terminated
·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016