20 results
·
23ms
·
Sources: EU EUDAMED, US FDA
EMIT VALPROIC ACID CONTROL
FDA 510(k)
FDA Class 1
·Clinical Toxicology
Oph.Forceps
FDA UDI
KATENA PRODUCTS, INC.·00857365004033·Graefe Iris Forceps, 1x2 Teeth, Straight
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209123292·KIT, MERET EFAK PRO X w' CGLE - RED
Momentum
FDA UDI
Ulrich Medical Usa, Inc.·00810076338040·Angled Hook, Right, Small
TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HOMELOX
FDA 510(k)
FDA Class 2
·Anesthesiology
TGS UKA SYSTEM
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, INC·Product code HSX·March 22, 2013
TGS UKA KNEE SYSTEM
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, INC.·Product code HSX·May 6, 2013
TGS UKA SYSTEM
FDA Adverse Event
Injury
·CAYENNE MEDICAL, INC·Product code HSX·February 12, 2014
TGS UKA SYSTEM
FDA Adverse Event
Injury
·CAYENNE MEDICAL, INC.·Product code HSX·September 25, 2014
TGS UKA KNEE SYSTEM
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, INC.·Product code HSX·September 10, 2013
TGS UKA KNEE SYSTEM
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, LLC·Product code HSX·August 14, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 8, 2014
UNKNOWN REJUVENATE HIP DEVICE
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·October 17, 2012
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 28, 2015
ENDOPATH ETS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GAG·October 14, 1997
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
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025