21 results · 31ms · Sources: EU EUDAMED, US FDA

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ENCORE 26 ADVANTAGE KIT

FDA 510(k)
FDA Class 2 ·Cardiovascular

NOVO Health Services, LLC

FDA UDI
NOVO HEALTH SERVICES, LLC·00812564031044·Basin Set, Open Heart

GUTTA PERCHA POINTS

FDA UDI
DiaDent Group International·08806383554688·Gutta Percha Points is used to root canal filin...

COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN

FDA 510(k)
FDA Class 1 ·General Hospital

QAB2A IGM ELISA KIT

FDA 510(k)
FDA Class 2 ·Immunology

2.4MM VA LOCKING SCREW STARDRIVE 22MM

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·June 25, 2013

KIWI VACUUM WITH PALM PUMP

FDA Adverse Event
Malfunction ·CLINICAL INNOVATIONS·Product code HDB·September 19, 2012

VA LOCKSCR Ø2.4 SELF-TAP L18 TAN

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code HRS·July 15, 2013

100MM MONOPOLAR NITINOL ELECTRODE

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code GXD·May 20, 2013

EQ WAY LIFT

FDA Adverse Event
Malfunction ·EZ WAY, INC.·Product code FSA·August 25, 2014

COLLEAUGE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 2011

EAGLE EYE PLATINUM SHORT TIP

FDA Adverse Event
Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER

FDA Adverse Event
Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER

FDA Adverse Event
Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

2.4MM TI LOCKING SCR SLF-TPN WITH STARDRIVE RECESS 18MM

FDA Adverse Event
Malfunction ·SYNTHES BETTLACH·Product code HWC·June 21, 2017

SCREW, FIXATION, BONE

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code HWC·December 24, 2015

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HWC·July 30, 2015

2.4MM TI LOCKING SCR SLF-TPN WITH STARDRIVE RECESS 18MM

FDA Adverse Event
Malfunction ·SYNTHES BETTLACH·Product code HWC·June 21, 2017

PLATE, FIXATION, BONE

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code HRS·October 24, 2015

Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

FDA Enforcement
Class II ·Terminated·GA Industries·May 6, 2015