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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QUICKIE PRIME CARDIOP. BYPASS PERF. INTR
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257009987·M.3 SOFT OA BRACE, VARUS, LEFT, SM
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489105626·PowerChem Neoprene Exam Gloves, Small
CODMAN®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780514985·CODMAN® Surgical Patties 1/2" x 1" (1.27cm x 2....
CODMAN
FDA UDI
Cerenovus, Inc.·20886704036507·CODMAN Surgical Patties 1/2 Inch x 1 Inch (1.27...
ACUMED
FDA UDI
Acumed LLC·10806378049125·Parallel Pin Guide, 5mm
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756016445·ARM SLING
SIMPLANT ORTHO ; VISTADENT 3D
FDA 510(k)
FDA Class 2
·Radiology
OTICON EARETTE HEARING AID #E17 HC
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
SURG PAT XRAY 1/2X1 -200
FDA Adverse Event
Malfunction
·RAYNHAM·Product code HBA·August 5, 2019
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 8, 2014
UNKNOWN RIGHT REJUVENATE/ABG II HIP
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
SURGICAL PATTIE, 1/2 X 1/2
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code HBN·December 10, 2015
SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. 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 1/2X1 Model/Catalog Number: 801402. 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
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