Tz Medical And Fda

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510(k) Premarket Notification - Food and Drug …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K102507

Device Name. AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR. Applicant. TZ MEDICAL, INC. 7272 SW DURHAM RD., #800. PORTLAND, …

510(k) Premarket Notification - accessdata.fda.gov

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?start_search=1&productcode=DRO&applicant=TZ%20MEDICAL%2C%20INC%2E

ProductCode: DRO Applicant: TZ MEDICAL, INC. Decision Date To: 02/05/2023 Results per Page 5 10 25 50 100 500

TZ Medical - INNOVATION MEETS VALUE

https://www.tzmedical.com/

TZ Medical is a company built by common ideas and innovations of people from the medical community-common sense products that better assist the medical field. Keith Romiti …

510(k) Premarket Notification - accessdata.fda.gov

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?start_search=1&productcode=FRO&knumber=&applicant=TZ%20MEDICAL%2C%20INC%2E

Device Classification Name: dressing, wound, drug: 510(k) Number: K040208: Device Name: NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT …

MAUDE Adverse Event Report: TZ MEDICAL, INC.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=13051706&pc=DRO

MAUDE Adverse Event Report: TZ MEDICAL, INC. DEFIBRILLATION ELECTRODES PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE) Follow …

MAY 11 2004 N L f - accessdata.fda.gov

https://www.accessdata.fda.gov/cdrh_docs/pdf4/K040208.pdf

The TZ Medical Neptune products have been tested and are consideredsafe and effective. With the exception of the Comfort-Band material andan adhesive interface between the …

MAUDE Adverse Event Report: TZ MEDICAL, INC.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=13306547&pc=FWW

Tz medical pannus retention system used during case on catheterization lab. Bilateral skin tears, noted on the groin area of the patient, required sutures. Search Alerts/Recalls New …

MAUDE Adverse Event Report: TZ MEDICAL, INC.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6989939&device_sequence_no=0

Patient was successfully defibrillated at 200j using the tz medical defib pads (p-211-z1) attached to the high output defibrillator in the operating room. Soot was seen at the left …

MAUDE Adverse Event Report: TZ MEDICAL, INC …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4411810&pc=DRF&device_sequence_no=1

TZ MEDICAL, INC CATHETER: Back to Search Results: Catalog Number CF-D7-AAA-NSDA: Device Problem Insufficient Information (3190) ... Was the Report Sent to FDA? …