9 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM 2200
FDA 510(k)
FDA Class 2
·Radiology
NEURO-TRAIN III (3)
FDA 510(k)
FDA Class 2
·Physical Medicine
TROJAN PASSION BERRY GEL
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
X3 TRIATHLON CS INSERT #3 9MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·May 13, 2014
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·April 12, 2013
PDS II (POLYDIOXANONE) SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAN·June 18, 2008
INJECTION GOLD PROBE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MIAMI·Product code KNS·April 19, 2011
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