18 results
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32ms
·
Sources: EU EUDAMED, US FDA
RANAWAT ESF TOTAL CONDYLAR KNEE
FDA 510(k)
FDA Class 2
·Orthopedic
BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS
FDA 510(k)
FDA Class 3
·Orthopedic
RE-ENTRANT CHAMBER, MODEL 1008 OR 44D
FDA 510(k)
FDA Class 2
·Radiology
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·January 27, 2025
CONV PIN IV FAT CLVE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·October 18, 2012
LANX LATERAL-SA SYSTEM
FDA Adverse Event
Malfunction
·LANX, INC.·Product code OVD·February 21, 2014
STAPLE, IMPLANTABLE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 28, 2015
AVAN TAP CORT SCR SS 4.5X26MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X58MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X48MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X56MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X60MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X20MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X52MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
M2A ACETABULAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·May 23, 2018
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·February 8, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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