18 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Medline ENfit OTC Feeding Syringe
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517628411·CoRoent Ant TLIF Ti, 10x12x28mm 15°
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113226·VITRECTOMY KNIFE 20GA (BX/5)
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113233·VITRECTOMY KNIFE 19GA (BX/5)
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113240·VITRECTOMY KNIFE 23GA (BX/5)
MODIFICATION TO ISOLA SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ATAC PAK ALP REAGENT KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCU-CHEK ® GUIDE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE, INC.·Product code NBW·August 5, 2022
T:SLIM G4 SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code OYC·February 15, 2017
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·August 19, 2019
CLINITRON AT HOME
FDA Adverse Event
Injury
·Product code INX·October 16, 2014
HIRES 90K
FDA Adverse Event
Injury
·ADVANCED BIONICS, LLC·Product code MCM·August 2, 2011
ALARIS PUMP MODULE
FDA Adverse Event
Death
·CAREFUSION CORPORATION·Product code FRN·June 24, 2013
PROTEGE RX CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·COVIDIEN·Product code NIM·February 9, 2023
RADIESSE INJECTABLE IMPLANT
FDA Adverse Event
Injury
·MERZ NORTH AMERICA, INC·Product code LMH·February 23, 2023
RADIESSE INJECTABLE IMPLANT
FDA Adverse Event
Injury
·MERZ NORTH AMERICA, INC·Product code LMH·February 23, 2023
SPIDER FX
FDA Adverse Event
Injury
·COVIDIEN·Product code NTE·February 9, 2023
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