18 results
·
21ms
·
Sources: EU EUDAMED, US FDA
BALANCE REHABILITATION UNIT (BRU)
FDA 510(k)
FDA Unclassified
·Unknown
ComfortGel Blue
FDA UDI
Respironics, Inc.·00606959043763·ComfortGel Blue Nasal Mask w/Headgear, Petite, ...
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108691979·Final Depth Pin for Ø3.25mm Implant
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108694406·LOCATOR Abutment Internal Hex. SP H4mm
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659182714·DCP compression plate f. 3.5mm _x000D_...
DCP compression plate f. 3.5mm screws, length 86mm/7 holes
FDA UDI
mahe medical gmbh·EMAH00200700850·DCP compression plate f. 3.5mm
screws...
PORTSETT
FDA 510(k)
FDA Class 2
·General Hospital
EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED)
FDA 510(k)
FDA Class 2
·Neurology
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·January 10, 2019
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·January 10, 2019
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·January 10, 2019
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 24, 2020
INFANT BIAS FLOW BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·April 26, 2011
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 22, 2013
SOFTCLIX LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·July 3, 2008
UNKNOWN ORTHOCORD
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code MAI·November 1, 2019
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 6, 2025
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012