13 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Capstone Control PTC Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169677807·SPACER 5031622 CONTROL PTC 24 DEG 16X22
Capstone Control Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169677906·SPACER 4031622 CONTROL 24 DEG 16X22
ENDOFLATOR 50
FDA Adverse Event
Malfunction
·KARL STORZ SE & CO. KG·Product code FCX·December 31, 2024
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0316920·Probe, 1.75" Egg, Steffee, Long, Straight, Impact
OSTEO IC FEMORAL AND TIBIAL NAILS AND OSTEO RETROGRADE/ANTEGRADE FEMORAL NAILS WITH T2 LOCKING SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
NUCLEOTOMY INTRADISCAL CATHETER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
FDA Enforcement
Class III
·Terminated·Karl Storz Endoscopy·May 20, 2020
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code FSA·April 2, 2013
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
FDA Adverse Event
Injury
·ALCON-FORT WORTH/ALCON LABORATORIES, INC.·Product code LPN·March 16, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·August 22, 2014
Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
FDA Recall
Terminated
·Karl Storz Endoscopy·Product code NKC·January 9, 2019
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