1,041 results
·
17ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Recall
×
25-LHP-828, HeNe Laser System, 35 mW
FDA Recall
Open, Classified
·PACIFIC LASERTECH, LLC·Product code RDW·March 1, 2024
25-LHP-928, HeNe Laser System, 25 mW
FDA Recall
Open, Classified
·PACIFIC LASERTECH, LLC·Product code RDW·March 1, 2024
N-LHP-928, HeNe Laser System, 35 mW
FDA Recall
Open, Classified
·PACIFIC LASERTECH, LLC·Product code RDW·March 1, 2024
Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as a power supply alone.
FDA Recall
Open, Classified
·Product code RFN·March 27, 2024
SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code JWH·November 18, 2013
SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code JWH·November 18, 2013
SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code JWH·November 18, 2013
SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code LXH·November 18, 2013
SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code JWH·November 18, 2013
SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code JWH·November 18, 2013
SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code JWH·November 18, 2013
SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code JWH·November 18, 2013
VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 2000 tests, IVD, Made in United States. Kit contains: 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer 3. Cartridge Set, 2 cation exchange analytical cartridges, 5 cation exchange Guard cartridges. 4. CD-ROM 1 - CD Rom with program parameters 5. Calibration/Diluent set - 2 levels, 3 vials each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water. 6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative, 7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps. 8. Instruction Manual. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
FDA Recall
Terminated
·Bio-Rad Laboratories, Inc.·Product code LCP·September 12, 2011
HooperHolmes Health & Wellness, Product K8303, each kit packed in an envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies and instructions. Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code LCP·January 9, 2011
Alere Blood Collection Kit (Carolina Care Plan), Product K6900, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions. Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code LCP·January 9, 2011
Appraise DBS Test Pak/HW-Kronos KROJI, Product K8603, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies and instructions. Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code LCP·January 9, 2011
Appraise A1C Test Pak Kit (IBM Care Advantage), Product K7200, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions. Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code LCP·January 9, 2011
A1CNOW+ with sampler 10-Test Kits (Product No: 3022), Metrika, Inc., Sunnyvale, CA 94085. (This test provides quantitative measurement of the percent of glycated hemoglobin (%A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is used by professional healthcare providers to monitor long-term glycemic control in people with diabetes. The product is sold as a kit with a disposable monitor and reagents for ten A1C tests and is suitable for use at the point-of-care.
FDA Recall
Terminated
·Metrika Inc·Product code LCP·August 31, 2007
D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules, CA 94547 The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, Ale} in whole blood. The separation is based on the principles of high performance liquid chromatography.
FDA Recall
Terminated
·Bio-Rad Laboratories, Inc.·Product code LCP·November 22, 2013
Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number: 10491449 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCHb, FMetHb, FHHb, nBili
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code KHP·August 24, 2015