20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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