11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER, MODELS K6275422, M6275423
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TI-DBLE LEAD CORT SCR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSB·August 24, 2018
GRAMS POLYESTER NONABSORBABLE SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
HUDSON NOVATION VENTILATOR TUBING SET, LONG
FDA Adverse Event
Malfunction
·TELEFLEX·Product code BZO·April 12, 2013
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 20, 2008
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 19, 2011
SYRINGE 1.0ML 31G TW 6MM BLS 400 SG
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code MEG·September 17, 2019
Affixus¿ Hip Fracture Nail 130¿ 13 mm x 180 mm, Item Number: 814513180
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 19, 2018
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