17 results · 19ms · Sources: EU EUDAMED, 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