42 results
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35ms
·
Sources: EU EUDAMED, US FDA
RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS
FDA 510(k)
FDA Unclassified
·Unknown
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040013892·Zirlux 16+ C3 98.5X18
Kwire tip protector Dia 1.2/1.6 mm sterile
FDA UDI
IN2BONES·03760225714775·Kwire tip protector Dia 1.2/1.6 mm sterile
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0112110·Tap, Cannulated, 4.75 mm
BD NEXIVA CLOSED IV CATHETER SYSTEM - DUAL PORT 22 GA 1.00 IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·May 12, 2021
OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)
FDA 510(k)
FDA Class 2
·Anesthesiology
STERILE BUTTON PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
CONTACT DETACH
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 15, 2025
MERSILENE TAPE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code KDC·November 13, 2018
CONTACT DETACH
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 15, 2025
SURE-T
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·April 23, 2025
VIBRANT SOUNDBRIDGE
FDA Adverse Event
Injury
·VIBRANT MED-EL HEARING TECHNOLOGY GMBH·Product code MPV·March 15, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·March 8, 2011
IDENTITY DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·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 Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
IODINE (I-125) SEEDS
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code KXK·September 28, 2016
IODINE (I-125) SEEDS
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code KXK·September 28, 2016
IODINE (I-125) SEEDS
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code KXK·September 28, 2016
IODINE (I-125) SEEDS
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code KXK·September 28, 2016
UNKNOWN MONO/POLYAXIAL SCREWS
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL CH·Product code NKB·September 10, 2021