21 results
·
20ms
·
Sources: EU EUDAMED, US FDA
TRANSFX ANGLED RODS
FDA 510(k)
FDA Class 2
·Orthopedic
Creation Willi Geller
FDA UDI
KLEMA Dentalprodukte GmbH·ECWG0032051·CC/ Transition Dentine TD-A4
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011003205000·Aderer 3-Prong pliers Extra-Mini, Premium-Line
NOBELACTIVE INTERNAL RP 4.3X8.5MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·August 17, 2020
NOBELACTIVE INTERNAL NP 3.5X8.5MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·September 9, 2020
NOBELACTIVE INTERNAL NP 3.5X8.5MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·September 9, 2020
NOBELACTIVE INTERNAL RP 4.3X8.5MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·August 17, 2020
CARONY
FDA 510(k)
FDA Class 1
·Physical Medicine
EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PRECISION SPECTRA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 2, 2024
NA
FDA UDI
Zimmer, Inc.·00889024066083·
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013
6083 AMBULANCE COT
FDA Adverse Event
Other
·STRYKER MEDICAL·Product code FPO·February 16, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 22, 2008
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code DQK·July 9, 2004
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; 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