51 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VENTURI MiNO TG600/14
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169631793·CURETTE 2143004 O25 DOUBLE SIDED UTERINE
V. Mueller
FDA UDI
STERIS CORPORATION·10885403279249·V. Mueller DISPOSABLE BIPOLAR FORCEPS
OsteoMed
FDA UDI
OSTEOMED LLC·00845694009089·4 Hole Straight Compression Plate
LEONE SPA
FDA UDI
LEONE SPA·08033707011620·CALIBRA 1ST MOL BANDS W/G8025-03 n.UL 4
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776149819·Ellik Evacuator, glass bowl only
SNORE GUARD
FDA 510(k)
FDA Class 2
·Dental
STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AXERA 2 ACCESS SYSTEM
FDA Adverse Event
Injury
·ARSTASIS INC.·Product code DYB·May 30, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·September 27, 2014
RESTORE ADVANCED RECHARGEABLE
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·June 23, 2011
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·December 18, 2013
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 1, 2020
GLIDEWIRE ADVANTAGE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 9, 2025
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 23, 2022
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·February 3, 2025
RADIFOCUS GUIDEWIRE ADVANTAGE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 12, 2024
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DQX·August 30, 2023
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·August 7, 2020
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·October 16, 2020