23 results
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23ms
·
Sources: EU EUDAMED, US FDA
METHADONE MICROPLATE EIA URINE APPLICATION
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526780798·LEVAMED ACTIVE ANKLE SUP SLVR R I
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040014028·Zirlux 16+ A4 98.5X20
Kwire tip protector Dia 1.2/1.6 mm sterile
FDA UDI
IN2BONES·03760225714782·Kwire tip protector Dia 1.2/1.6 mm sterile
PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
3D HDRAULIC FINE MICROMANIPULATOR MO-188NE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CM TITAMAX IMPLANT 4.0X7
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·April 13, 2018
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code JDS·March 31, 2014
ENDOPATH ETS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·November 7, 1997
PLATE
FDA Adverse Event
Injury
·DEPUY SYNTHES·Product code HRS·May 15, 2014
UNKNOWN CAGE/SPACER
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code MAX·August 28, 2019
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·March 8, 2011
IDENTITY DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2008
ENDOPATH ETS FLEX
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·February 6, 1998
SCREW
FDA Adverse Event
Injury
·DEPUY SYNTHES·Product code HWC·May 15, 2014
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·May 7, 2022
STENT - VASCULAR RECONSTRUCTION
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code NJE·December 9, 2021
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
Oxford Femoral Knee System REF 154600, LOT 2272736, WARNING DO NOT RESTERILIZE, STERILE UNLESS PACK DAMAGED, BIOMET UK Ltd, (510K# K011138) This device is used in partial knee replacement surgery as a result of patients who are experiencing degenerative arthritis.
FDA Recall
Terminated
·Product code HRY·April 22, 2011