18 results · 23ms · Sources: EU EUDAMED, US FDA

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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