18 results · 23ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

CURELLE, PREFERRED CURELLE, CUTEQ 2.5

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Safco Micro Applicators

FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310206283·Safco endo nano applicator green POD

Channels

FDA UDI
HENRY SCHEIN, INC.·10304040162320·Channels One Paper Points Small

Midway Select

FDA UDI
MIDWAY DENTAL SUPPLY, LLC·00843717108535·Dental Dam Clamp Forceps - IV-Type

BD CTGCTV2 FOR BD MAX¿ SYSTEM (US

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code LSL·March 9, 2023

WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·January 8, 2026

EMBLEM S-ICD

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LWS·June 2, 2023

EMBLEM S-ICD

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LWS·June 2, 2023

EMBLEM S-ICD

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LWS·June 2, 2023

FREESTYLE

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 31, 2007

840 VENTILATOR

FDA Adverse Event
Malfunction ·PURITAN BENNETT CORP.·Product code CBK·February 10, 2011

ACCU-CHEK ® SPIRIT COMBO

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·August 19, 2014

9MM TI CANNULATED TIBIAL NAIL-EX/375MM-STERILE

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code JDS·January 6, 2016

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024