18 results · 20ms · Sources: EU EUDAMED, 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