18 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CORONARY PERFUSION CONNECTOR PLUG
FDA 510(k)
FDA Class 2
·Cardiovascular
CODMAN®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780514954·CODMAN® Surgical Patties 1/4" x 1/4" (0.64cm x ...
CODMAN
FDA UDI
Cerenovus, Inc.·20886704036477·CODMAN Surgical Patties 1/4 Inch x 1/4 Inch (0....
CODMAN SURGICAL PATTIES
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF, INC.·Product code HBA·July 11, 2003
AVIATOR TRANSPORT INCUBATOR
FDA 510(k)
FDA Class 2
·General Hospital
COAXIAL INTRODUCER SET
FDA 510(k)
FDA Class 2
·Cardiovascular
ASR UNI FEMORAL IMPL SIZE 51
FDA Adverse Event
Injury
·DEPUY INTL., LTD - 8010379·Product code KWA·May 8, 2014
UNKNOWN REJUVENATE HIP DEVICE
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·October 17, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 25, 2007
SURG PATXRAY 1/4X1/4-200
FDA Adverse Event
Malfunction
·RAYNHAM·Product code HBA·May 17, 2023
SURGICAL PATTIE, 1/2 X 1/2
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code HBN·November 11, 2015
CODMAN SURGICAL PATTIES
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code HBA·November 9, 2015
Codman 1/4 x 1/4" Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1399
FDA Recall
Terminated
·Codman & Shurtleff, Inc.·Product code HBA·July 16, 2010
SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. 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 1/4X1/4 Model/Catalog Number: 801399. 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
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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