15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIAISON XL ANALYZER
FDA 510(k)
FDA Class 2
·Microbiology
K121116
FDA UDI
Life Spine, Inc.·00190837016029·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837016043·
HIGH-WAVE
FDA UDI
Denplus Inc·D8451141116·HIGH-WAVE, ORI, 454 g
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837016258·
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321411160·
HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH
FDA 510(k)
FDA Class 2
·Cardiovascular
SUPER QUICKANCHOR PLUS
FDA 510(k)
FDA Class 2
·Orthopedic
Widex
FDA UDI
Widex A/S·05706069886603·WIDEX MOMENT MRB0 (Dark cherry ) 440, RIC 10
Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code CBK·April 18, 2022
Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)
FDA Enforcement
Class I
·Ongoing·GE Healthcare, LLC·June 15, 2022
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·October 3, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 3, 2013
ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL CO.·Product code MTA·June 22, 2011
Alcon Custom Ophthalmic Surgical Procedure Packs
FDA Enforcement
Class II
·Terminated·Alcon Research, LLC·April 7, 2021