12 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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TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE
FDA 510(k)
FDA Class 2
·Orthopedic
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0311930·Probe, 1.75 inch, Egg, Steffee, Long, Curved
OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500
FDA 510(k)
FDA Class 2
·Orthopedic
OMNIPORT HAND AND INSTRUMENT ACCESS DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SELOX JT 45
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·April 2, 2013
BRAVO PH MONITORING SYSTEM AND ACCESSORIES
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·March 17, 2011
PUMP MMT-512LNAL PRDGM INS CL EN US LN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·April 17, 2008
G7 OSSEOTI 3 HOLE SHELL 50MM D 0MM D
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·February 4, 2021
LINER NEUTRAL 36 MM I.D. SIZE D FOR USE WITH G7 ACETABULAR SYSTEM ONLY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·February 4, 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
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016