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REPROCESSED HOT BIOPSY FORCEPS

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

MedGyn Pessary Dish w/o support # 7

FDA UDI
MEDGYN PRODUCTS, INC.·M803050136·Dish Pessary is used to treat uterine prolapse.

VISUALINE BARBITURATES DIPSTRIP TEST

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

DRIP ALERT

FDA 510(k)
FDA Class 2 ·General Hospital

Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.

FDA Enforcement
Class II ·Terminated·Technomed Europe·January 19, 2022

AEQ REV II GLENOID BASEPLATE DIA 25MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code PHX·July 1, 2025

AEQUALIS REVERSED BASE PLATE TA6V LONG PEG WITH HA

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·March 13, 2025

AEQ REV GLENOID BASEPLATE 29MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·March 6, 2025

ENDOTAK RELIANCE

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVY·April 10, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·August 30, 2014

STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 1, 2011

AEQUALIS REVERSED MULTIDIRECTIONAL GLENOID PLATE HA

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·March 25, 2024

D.4,5MM COMPRESSION SCREW L.32MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·January 7, 2025

D.4,5MM COMPRESSION SCREW L.23MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·January 7, 2025

RECOVERY FILTER SYSTEM

FDA Adverse Event
Injury ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·March 25, 2020

BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·July 10, 2019

AEQ REV GLENOID BASEPLATE 29MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·May 21, 2024

AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

FDA Enforcement
Class II ·Terminated·Teleflex Medical·February 18, 2015

Alpha-Omega Services, Inc. Product No: SPECIAL-NFV Description: CUSTOM FLEXIGUIDE NEEDLE, SERIES 15, WITH FEMALE LUER AND STYLET WITH MALE LUER 28CM, SET OF 100 Quantity: 1/PKG Lot No: K00136 L-SPECIAL- NFV. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method.

FDA Recall
Terminated ·Alpha Omega Services Inc·Product code IWJ·November 15, 2007

Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018