23 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ARGEDENT 54 (5 dwt)
FDA UDI
ARGEN CORPORATION, THE·D818120182·Gold based noble metal
Action®
FDA UDI
ACTION PRODUCTS, INC.·00089904001924·The Professional™
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319703601·Gerald Tissue Forceps 7" (17.5cm), straight, 1x...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197032247·Potts-Smith Vascular Scissors
40° an...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197526098·Cushing Laminectomy Ronguer downwards an
gled 2...
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NETILMICIN (0.12-32 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
SALVIN DENTAL SPECIALTIES FIXATION SCREW
FDA 510(k)
FDA Class 2
·Dental
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 23, 2023
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·December 20, 2018
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 11, 2019
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code OYC·August 21, 2019
IN00087 CLERMONT FERRAND PH
FDA Adverse Event
Death
·SORIN GROUP ITALIA·Product code DWF·March 7, 2014
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·January 7, 2016
PRECISE PRO RX CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIM·May 20, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code CAW·September 25, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 2011
INSPIRE 6F HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 21, 2022
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·June 8, 2016
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
FDA Enforcement
Class II
·Ongoing·Auris Health, Inc·February 25, 2026