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

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RS NITRILSTST MEDICAL EXAMINATION GLOVES, POWDERED (NON STERILE) BLUE

FDA 510(k)
FDA Class 1 ·General Hospital

Premier Cavity Prep

FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783008319·CPI Margin Trimmer-Black DE_BC 77/78

TruForm

FDA UDI
Rmo, Inc.·00885797099853·MN 2ND BI BD KT N/L UNIV 123

Alpha-Tec Systems

FDA UDI
Alpha-TEC Systems, Inc.·00816085020440·Gram Stain QC Slides (10 Pk)

Generic Buccal Tubes

FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746125409·TUBE MAND MOLAR 018 INCONEL TQ=0 R=0 5.5MM

LIFEPAK® 12 defibrillator/monitor

FDA UDI
PHYSIO-CONTROL, INC.·00885074555386·LP12AABCABABBABAAAAAAAAALP12 MONITOR-DEFIB

Straight Black Hose, Female Bayonet to Female Bayonet, 9.8ft (3m), Siemens

FDA UDI
SUNTECH MEDICAL, INC.·10840935111702·

WAVEWRITER ALPHA? PRIME

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 17, 2026

MENICON SF-P

FDA 510(k)
FDA Class 2 ·Ophthalmic

ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S

FDA 510(k)
FDA Class 2 ·General Hospital

CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

FDA Adverse Event
Malfunction ·DATASCOPE CORP. - MAHWAH·Product code DSP·February 4, 2022

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

PRECISION XTRA

FDA Adverse Event
Malfunction ·Product code NBW·February 28, 2011

LOGICAL KIT

FDA Adverse Event
Malfunction ·SMITHS MEDICAL·Product code DRS·February 21, 2008

BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·August 25, 2020

smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024