17 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BD Insulin Syringe (0.3mL)
FDA 510(k)
FDA Class 2
·General Hospital
Mepilex® Up
FDA UDI
Mölnlycke Health Care AB·07333350001643·Mepilex Up, 20x20 cm US
Oticon
FDA UDI
Oticon A/S·05707131376428·OPN PLAY 1, MINIRITE T 312 2.4G C046
Dexter Endoscope Arm
FDA UDI
Aktormed GmbH·04260463844993·customized SOLOASSIST II for Dexter, incl. Powe...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694020039·FPS 2.7mm Washer
OsteoMed
FDA UDI
OSTEOMED LLC·00845694073882·FPS 2.7 Washer Sterile Qty 5
BIOMERIX COMPOSITE SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENVIRON-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 11, 2018
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HSB·July 1, 2014
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HSB·June 30, 2014
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 30, 2014
FISHER & PAYKEL
FDA Adverse Event
Other
·FISHER & PAYKEL·Product code BZE·January 12, 2006
POWER LOAD
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 9, 2013
SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HSB·June 30, 2014
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023