9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS
FDA 510(k)
FDA Class 2
·General Hospital
SANICLAVE 102, MODEL RS-SC-102
FDA 510(k)
FDA Class 2
·General Hospital
PEDICLE SCREW MUST LT 15MM SHORT - PEDICLE SCREW Ø4.5X30 CANN
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·November 8, 2023
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·August 10, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 6, 2014
INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·July 12, 2013
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018