15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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K-FIX
FDA 510(k)
FDA Class 2
·Orthopedic
16PW - Cal OSHA
FDA UDI
Certified Safety Manufacturing, Inc.·00766588025971·16PW - Cal OSHA
STERILMED REPROCESSED COMPRESSION SLEEVES
FDA 510(k)
FDA Class 2
·Cardiovascular
CN ACQUISITION STATION
FDA 510(k)
FDA Class 2
·Radiology
CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code KNS·March 15, 2019
G7 NEUTRAL E1 LINER 32MM F
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·May 4, 2021
HEARTWARE VENTRICULAR ASSIST SYSTEM-SEWING RING
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·September 11, 2018
HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code JXG·March 27, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·March 17, 2011
NEXSTENT MONORAIL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIM·April 1, 2008
CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code KNS·February 4, 2019
CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code KNS·August 8, 2018
CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code KNS·August 8, 2019
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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018