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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device blood pressure cuff
Regulation Description Blood pressure cuff.
Definition A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.
Product CodeDXQ
Regulation Number 870.1120
Device Class 2


Premarket Reviews
ManufacturerDecision
ANDON HEALTH CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 1
KOVEN TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO FREE TRADE ZONE TENSO MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 1
PINGHU SAMA MEDICAL PACKING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI GOAHUI RUBBER AND PLASTIC COMPANY
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN VISTAR MEDICAL SUPPLIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SPACELABS HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU SUNSPIRIT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material Separation 59
Unraveled Material 26
Break 23
Flaked 14
Difficult to Remove 13
Material Fragmentation 9
Material Frayed 7
Adverse Event Without Identified Device or Use Problem 6
Appropriate Term/Code Not Available 6
Material Deformation 6
Peeled / Delaminated 5
Uncoiled 5
Difficult to Advance 3
Fracture 3
Material Split, Cut or Torn 3
Kinked 3
Stretched 3
Detachment of Device or device Component 2
Degraded 2
Material Protrusion / Extrusion 2
Material Integrity Problem 2
Split 2
Material Twisted / Bent 2
Wire 2
Sticking 2
Occlusion Within Device 2
Detachment Of Device Component 1
Defective Device 1
Delivered as Unsterile Product 1
Deformation Due to Compressive Stress 1
Device Operates Differently Than Expected 1
Device Contamination with Chemical or Other Material 1
Human Factors Issue 1
Device Contaminated during manufacture or shipping 1
Torn Material 1
Retraction Problem 1
Unintended Movement 1
Use of Device Problem 1
Guidewire 1
Bent 1
Contamination / decontamination Problem 1
Total Device Problems 227

Recalls
Manufacturer Recall Class Date Posted
1 ICU Medical, Inc. II May-09-2018
2 Suntech Medical, Inc. II Aug-14-2019

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