39 results · 18ms · Sources: EU EUDAMED, US FDA

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Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505, nonsterile; (2) Calibrate CCX-O, 7 x 10 x 25mm 10 degrees, Part #325-07102510, nonsterile; (3) Calibrate CCX-O, 7 x 10 x 25mm 15 degrees, Part #325-07102515, nonsterile; (4) Calibrate CCX-O, 7 X 10 X 30mm 5 degrees, Part #325-07103005, nonsterile; (5) Calibrate CCX-O, 7 x 10 x 30mm 10 degrees, Part #325-07103010, nonsterile; (6) Calibrate CCX-O, 7 x 10 x 30mm 15 degrees, Part #325-07103015, nonsterile; (7) Calibrate CCX-O, 7 x 10 x 35mm 10 degrees, Part #325-07103510, nonsterile; (8) Calibrate CCX-O, 7 x 10 x 35mm 15 degrees, Part #325-07103515, nonsterile; (9) Calibrate CCX-O, 9 x 10 x 25mm 5 degrees, Part #325-09102505, nonsterile; (10) Calibrate CCX-O, 9 x 10 x 25mm 10 degrees, Part #325-09102510, nonsterile; (11) Calibrate CCX-O, 9 x 10 x 30mm 5 degrees, Part #325-09103005, nonsterile; (12) Calibrate CCX-O, 9 x 10 x 30mm 10 degrees, Part #325-09103010, nonsterile; (13) Calibrate CCX-O, 11 x 10 x 30mm 10 degrees, Part #325-11103010, nonsterile; (14) Calibrate CCX-S, 7 x 10 x 22mm 5 degrees, Part #326-07102205, nonsterile; (15) Calibrate CCX-S, 7 x 10 x 22mm 10 degrees, Part #326-07102210, nonsterile; (16) Calibrate CCX-S, 7 x 10 x 22mm 15 degrees, Part #326-07102215, nonsterile; (17) Calibrate CCX-S, 7 x 10 x 26mm 5 degrees, Part #326-07102605, nonsterile; (18) Calibrate CCX-S, 7 x 10 x 26mm 10 degrees, Part #326-07102610, nonsterile; (19) Calibrate CCX-S, 7 x 10 x 26mm 15 degrees, Part #326-07102615, nonsterile; (20) Calibrate CCX-S, 7 x 10 x 30mm 10 degrees, Part #326-07103010, nonsterile; (21) Calibrate CCX-S, 9 x 10 x 22mm 5 degrees, Part #326-09102205, nonsterile; (22) Calibrate CCX-S, 9 x 10 x 22mm 10 degrees, Part #326-09102210, nonsterile; (23) Calibrate CCX-S, 9 x 10 x 26mm 5 degrees, Part #326-09102605, nonsterile; (24) Calibrate CCX-S, 9 x 10 x 26mm 10 degrees, Part #326-09102610, nonsterile; and (25) Calibrate CCX-S, 11 x 10 x 26mm 10 degrees, Part #326-11102610, nonsterile. Convenience kits containing affected implants: (1) Calibrate CCX Oblique Implants, REF CLCCXOIMPA, containing 24 implants/kit, nonsterile; and (2) Calibrate CCX Straight Implants, REF CLCCXSIMPA, containing 36 implants/kit, nonsterile.

FDA Recall
Open, Classified ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code MAX·December 15, 2024

Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit for CCX analyzer Catalog # 35238 Intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Ca++, total hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), reduced hemoglobin (HHb), Oxygen content (O2Ct) and Oxygen capacity (O2Cap) in heparinized whole blood; Na+, K+, CL-; Ca++, Mg++, Glucose heparinized whole blood, serum, or plasma.

FDA Recall
Terminated ·Nova Biomedical Corporation·Product code CGL·August 11, 2008

CCX Operating Software , Version 4.08

FDA Recall
Terminated ·Nova Biomedical Corporation·Product code CHL·January 27, 2006

Stat Profile Critical Care PLUS (CCX) Analyzer Catalog Number: 37413

FDA Recall
Terminated ·Nova Biomedical Corporation·Product code CHL·January 27, 2006

Stat Profile Critical Care (CCX) Analyzer Catalog Number: 35942

FDA Recall
Terminated ·Nova Biomedical Corporation·Product code CHL·January 27, 2006

Stat Profile Critical Care Xpress CCX+ Analyzer Catalog Number: 37413

FDA Recall
Terminated ·Nova Biomedical Corporation·Product code CHL·March 30, 2004

Stat Profile Critical Care Xpress (CCX) Analyzer Catalog Number: 35942

FDA Recall
Terminated ·Nova Biomedical Corporation·Product code CHL·March 30, 2004

Stat Profile Critical Care Xpress CCX+ (R) Anaylzer Catalog NUmber: 37555 R= Refurbished

FDA Recall
Terminated ·Nova Biomedical Corporation·Product code CHL·March 30, 2004

Stat Profile Critical Care Xpress CCX (R) Analyzer Catalog Number: 37562 R= Refurbished

FDA Recall
Terminated ·Nova Biomedical Corporation·Product code CHL·March 30, 2004

Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes

FDA Recall
Terminated ·Liberty Medical Supplies·Product code FMF·February 24, 2003

Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes

FDA Recall
Terminated ·Liberty Medical Supplies·Product code FMF·February 24, 2003

Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes

FDA Recall
Terminated ·Liberty Medical Supplies·Product code FMF·February 24, 2003

Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400

FDA Recall
Terminated ·Aspen Surgical Products, Inc.·Product code CCX·July 23, 2021

Allen Medical C-Flex, Polar Head Positioner Catalog Number: A-70700-A1 Product is a medical device used to maintain the position of an anesthetized patient during surgery.

FDA Recall
Terminated ·Allen Medical Systems, Inc. One Post Office Square·Product code CCX·November 27, 2007

Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100

FDA Recall
Terminated ·Aspen Surgical Products, Inc.·Product code CCX·July 23, 2021

Medline procedural kits labeled as: 1) BABY CARE KIT UNIV, Pack Number DYKL1025; 2) BABY CARE KIT UNIV, Pack Number DYKL1025H

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code CCX·April 8, 2024

Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 31151090 Product Usage: The device is intended to provide padding under the patient, and help maintain the position of an anesthetized patient during surgery.

FDA Recall
Terminated ·Covidien LLC·Product code CCX·May 8, 2014

Allen C-Flex Head Positioning System non-invasive medical device used to support a patient's head during spine surgery Catalog Numbers: A-70700 and A-70701-2

FDA Recall
Terminated ·Allen Medical Systems, Inc. One Post Office Square·Product code CCX·November 16, 2011

Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300

FDA Recall
Terminated ·Aspen Surgical Products, Inc.·Product code CCX·July 23, 2021

CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC

FDA Recall
Open, Classified ·Terumo Cardiovascular Systems Corporation·Product code DTZ·March 1, 2023