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

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BCI 3403 SLEEP SCREENING PULSE OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

Endo Carry-on Procedure Kit

FDA UDI
MEDIVATORS INC.·00677964153297·Endo Carry-on Procedure Kit contains Basin, Via...

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·00304040014271·Zirlux 16+ C2 98.5X22

PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SLEEP PAT 200 DEVICE

FDA 510(k)
FDA Class 2 ·Anesthesiology

9616240-2006-00341

FDA Adverse Event
Malfunction ·Product code FII·June 14, 2006

9616240-2006-00332

FDA Adverse Event
Other ·Product code FII·June 1, 2006

PHOENIX

FDA Adverse Event
Malfunction ·GAMBRO DASCO·Product code FII·May 10, 2006

9616240-2006-00339

FDA Adverse Event
Malfunction ·Product code FII·June 9, 2006

9616240-2006-00340

FDA Adverse Event
Malfunction ·Product code FII·June 9, 2006

9616240-2006-00350

FDA Adverse Event
Malfunction ·Product code FII·June 23, 2006

9616240-2006-00345

FDA Adverse Event
Malfunction ·Product code FII·June 14, 2006

CADD MEDICATION CASSETTE

FDA Adverse Event
Malfunction ·NULL·Product code FPA·February 4, 2022

PHOENIX

FDA Adverse Event
Malfunction ·GAMBRO DASCO·Product code FII·May 10, 2006

PHOENIX

FDA Adverse Event
Malfunction ·GAMBRO DASCO·Product code FII·May 10, 2006

STRATTICE

FDA Adverse Event
Injury ·LIFECELL·Product code FTM·May 26, 2011

OPTI-FREE PUREMOIST MPDS

FDA Adverse Event
Injury ·ALCON - FORT WORTH / ALCON LABORATORIES, INC.·Product code LPN·March 15, 2013

PRECISION XTRA

FDA Adverse Event
Malfunction ·Product code NBW·March 8, 2011

TENDRIL ST

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008

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