13 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VENA CAVA CANNULAE
FDA 510(k)
FDA Class 2
·Cardiovascular
CODMAN®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780514930·CODMAN® Surgical Patties 1/4" x1 1/2" (0.64cm x...
CODMAN
FDA UDI
Cerenovus, Inc.·20886704036453·CODMAN Surgical Patties 1/4 Inch x 1 1/2 Inches...
Oph.Forceps
FDA UDI
KATENA PRODUCTS, INC.·00852979003588·Rhein ICL Retrieval Forceps, Angled
ACUMED
FDA UDI
Acumed LLC·10806378049088·3.8mm Drill, 5.0mm Shank, QR
Ultrasonic Mesh Nebulizer
FDA 510(k)
FDA Class 2
·Anesthesiology
QUICKSCREEN PRO DRUG CUP, MODEL 9195X
FDA 510(k)
FDA Class 2
·Clinical Toxicology
INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·May 8, 2014
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 18, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 25, 2007
SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
FDA Enforcement
Class II
·Ongoing·Integra LifeSciences Corp.·November 6, 2024
SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code HBA·September 20, 2024
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012