12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES
FDA 510(k)
FDA Class 2
·Neurology
PERICSCOPE, MODEL # PERISC1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503
FDA 510(k)
FDA Class 2
·Cardiovascular
PLUM 4-PORT 15 FLTR 2CLV PE LINE 216CM
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·June 27, 2013
RETROFLEX 3 INTRODUCER SHEATH SET
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYB·April 23, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 2, 2011
EPIC PLUS DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
BIOLOX OPTION, HEAD, S, 44/-3.0, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·December 12, 2018
UNKNOWN HIP FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·February 3, 2021
TRI-LOCK BPS SZ 4 HI OFFSET
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·November 4, 2015
TRI-LOCK BPS SZ 7 STD OFFSET
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC·Product code KWA·November 4, 2015
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