20 results
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14ms
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Sources: EU EUDAMED, US FDA
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software:TKA 2.0.fr.1+TKA 1.0.1.fr.1+PKA3.0.2.fr. Application Part Number: 700002190743-04
FDA Recall
Open, Classified
·Stryker Orthopaedics·Product code OLO·April 15, 2024
Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
FDA Recall
Open, Classified
·Philips North America LLC·Product code MKJ·February 9, 2021
MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYNC1816, 15 Fr; 2. DYND10350, 15 Fr.
FDA Recall
Open, Classified
·Product code OHR·May 4, 2026
Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-07155-UPM
FDA Recall
Open, Classified
·ARROW INTERNATIONAL, LLC·Product code OES·April 21, 2026
Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (French language), DCF-E110SG-IT/1 (Italian language)
FDA Recall
Open, Classified
·Defibtech, LLC·Product code MKJ·March 18, 2025
Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple iOS 17.4 and Apple iOS 17.5, a component of the Arial Emergency and Nurse Call System.
FDA Recall
Open, Classified
·Securitas Healthcare LLC·Product code IQA·April 11, 2024
MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYND13508 - 08 Fr; 2. DYND13510 - 10 Fr; 3. DYND13512 - 12 Fr; 4. DYND13514 - 14 Fr; 5. DYND13515 - 15 Fr; 6. DYND13516 - 16 Fr; 7. DYND13518 - 18 Fr; 8. DYND13520 - 20 Fr; 9. DYND13522 - 22 Fr; 10. DYND13614 - 14 Fr; 11. DYND13616 - 16 Fr.
FDA Recall
Open, Classified
·Product code EYB·May 4, 2026
AirTouch F20 Full Face Mask and User Guide
FDA Recall
Open, Classified
·Product code BZD·November 20, 2023
AirFit F20 Full Face Mask and User Guide
FDA Recall
Open, Classified
·Product code BZD·November 20, 2023
AirFit N10 Nasal Masks and User Guide
FDA Recall
Open, Classified
·Product code BZD·November 20, 2023
AirFit F30i Full Face Mask and User Guide
FDA Recall
Open, Classified
·Product code BZD·November 20, 2023
AirFit F30 Full Face Mask and User Guide
FDA Recall
Open, Classified
·Product code BZD·November 20, 2023
AirFit N20 Nasal Mask and User Guide
FDA Recall
Open, Classified
·Product code BZD·November 20, 2023
AirTouch N20 Nasal Mask and User Guide
FDA Recall
Open, Classified
·Product code BZD·November 20, 2023
Medline Leg bag, REF DYND12578
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code FAQ·October 19, 2023
Medline Leg bag, REF DYND12574
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code FAQ·October 19, 2023
Medline Leg bag, REF URO12573
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code FAQ·October 19, 2023
Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece which is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities Part number: 00880000010
FDA Recall
Open, Classified
·Zimmer Surgical Inc·Product code GFD·September 5, 2023
CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software Uploader versions: 3.1.5.000 3.1.2.000
FDA Recall
Open, Classified
·Medtronic Inc.·Product code MDS·November 12, 2020
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack Model/Catalog Number: STP-AT-012 Software Version: N/A Product Description: Dexcom G7 US Retail Sensor/Transmitter 1-pack Component: Dexcom G7 Continuous Glucose Monitoring System
FDA Recall
Open, Classified
·Dexcom, Inc.·Product code QBJ·May 27, 2026