10 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SMITH & NEPHEW, INC. REVISION KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LGN PRSFT STEM 10MMX220MM STRT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·October 19, 2017
SOFTLASE - SURGICAL DIODE LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ISOBAR SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER
FDA Adverse Event
Injury
·DIGITAL ANGEL CORPORATION/ JAMM TECHNOLOGIES·Product code NRV·August 5, 2022
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 12, 2013
TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·February 25, 2011
VITALITY
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code KRG·May 8, 2008
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970505, Catalog No.REF 06597050, 2) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO S PG, Item Number H787065970525, Catalog No.REF 06597052, 3) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO A PG, Item Number H787065970545, Catalog No.REF 06597054 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
FDA Enforcement
Class III
·Terminated·Angiodynamics, Inc.·December 28, 2016
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