22 results · 20ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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