13 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
CHS
FDA UDI
Smith & Nephew, Inc.·03596010062314·AMBI COMPRESSION HIP SCREW PLATE 12SL 260MM 145D
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172974032·UniTip High Resolution Catheter 12F
LIC INSTRUMENT PROCESSING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
I-STAT CG8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·January 5, 2022
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·February 1, 2022
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 21, 2024
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·May 20, 2013
FLIXENE GRAFTS
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORP.·Product code DSY·September 24, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 13, 2011
SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.
FDA Enforcement
Class I
·Ongoing·Philips North America Llc·July 3, 2024
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018