17 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ISOLATION GOWN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Medline Industries, Inc.
FDA UDI
MEDLINE INDUSTRIES, INC.·10888277998018·CVHP MD BARRIER KIT
NA
FDA UDI
Zimmer, Inc.·00889024135260·
NA
FDA UDI
Zimmer, Inc.·00889024135239·
Minimally Invasive Solutions™ Technology
FDA UDI
Zimmer, Inc.·00887868550768·
NA
FDA UDI
Zimmer, Inc.·00889024135246·
NA
FDA UDI
Zimmer, Inc.·00889024135253·
Minimally Invasive Solutions™ Technology
FDA UDI
Zimmer, Inc.·00887868550775·
SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL
FDA 510(k)
FDA Class 2
·Cardiovascular
GastroFlush
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ELMED
FDA UDI
ELMED INCORPORATED·00842180163041·MIS ANTEROLATERAL LIT RETRACTOR, STRIAGHT
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·October 10, 2012
ACCU-CHEK ADVANTAGE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·September 27, 2007
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 3, 2013
NAMIC Convenience Kit, 3 VALVE KIT, UPN H749600709971, REF/Catalog No. 60070997, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
FDA Enforcement
Class II
·Terminated·Navilyst Medical, Inc·March 4, 2015
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024