18 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ORTHROPRO HEMI TOE
FDA 510(k)
FDA Class 2
·Orthopedic
Sklar®
FDA UDI
SKLAR CORPORATION·10649111154683·ROUND SCALPEL HANDLE STRAIGHT
JET THERAPY
FDA 510(k)
FDA Class 1
·Physical Medicine
BIOPLATE RESORBABLE BONE SCREW
FDA 510(k)
FDA Class 2
·Dental
BHR MODULAR HEAD 46MM
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code KWY·January 4, 2018
COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 19, 2011
COLONRING/ COMPRESSION ANASTOMOSIS RING (CAR27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 19, 2011
COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 19, 2011
COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 19, 2011
56MM AND R3 ACETABULAR SHELL
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBL·September 14, 2018
COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 19, 2011
COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 26, 2011
COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 12, 2011
M2A 38MM MOD HD STD NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·April 17, 2013
8800
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·March 21, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·June 19, 2008
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015