23 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VIVIX-M
FDA 510(k)
FDA Class 2
·Radiology
SpheRx
FDA UDI
Nuvasive, Inc.·00887517443168·SpheRx® II Hook, 6mm Reduced Tip Wide
15L8w Transducer
FDA UDI
SIEMENS MEDICAL SOLUTIONS USA, INC.·04056869002927·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694022712·FPS 2.7mm 6 Hole Oblique L Compression Plate Left
Perfect Fit
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377021237·Perfect Fit™ SUM Module with cable - Pediatric
Perfect Fit
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377021220·Perfect Fit SUM Module with cable - Adult
BD DifcoTM Neisseria Meningitidis Antisera Group Y 241113, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton, Dickinson and Company, Sparks, MD 21152. The product is packaged in 100 vial units For use in slide agglutination tests for serotyping Neisseria Meningitidis.
FDA Recall
Terminated
·BD Diagnostic Systems Lee Laboratories·Product code GTJ·September 6, 2007
BD DifcoTM Neisseria Meningitidis Antiserum Group Y 241113, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton, Dickinson and Company, Sparks, MD 21152. The product is packaged in 100 vial units For use in slide agglutination tests for serotyping Neisseria Meningitidis.
FDA Recall
Terminated
·BD Diagnostic Systems Lee Laboratories·Product code GTJ·September 6, 2007
OsteoMed
FDA UDI
OSTEOMED LLC·00845694077002·FPS 2.7 6 Hole Oblique Left L Compresson Plate ...
Resascope RS-01/B
FDA 510(k)
FDA Class 2
·Orthopedic
SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE
FDA 510(k)
FDA Class 2
·Cardiovascular
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 27, 2023
VERSYS HIP SYSTEM FEMORAL STEM FIBER METAL MIDCOAT COLLARED
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KWY·November 21, 2008
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 17, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 22, 2013
The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into a vein, a handle with start/stop button, and a connector cable. The catheter shaft has a heating element that is energized by the digiRF radiofrequency generator, which is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter. A button on the catheter (or a foot pedal attached to the generator) begins an automated treatment cycle of 20 seconds long at a set temperature of 120 ¿C, and the treatment stops automatically when complete. The catheter is used within a sterile operative field, while the generator remains outside the sterile operative field at all times.
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·November 20, 2024
BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020