14 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CHROMA ZONE COLOR STAIN
FDA 510(k)
FDA Class 2
·Dental
SMITH & NEPHEW PORPS & TORPS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 17, 2013
SCORPIO M-DOME PATELLA
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·April 13, 2011
ZENITH AAA ILIAC LEG DELIVERY SYSTEM
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·June 17, 2008
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·March 24, 2026
VICRYL POLYGLACTIN 910 SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·March 24, 2026
PDS II POLYDIOXANONE SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·March 24, 2026
NYLON SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAR·March 24, 2026
PROLENE POLYPROPYLENE SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·March 24, 2026
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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