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WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

NVM5

FDA UDI
Nuvasive, Inc.·00887517070708·NVM5 Clips Sheath, Dynamic Stimulation

JAW INS. BULLET NOSE GRASPER 5MM 310MM

FDA Adverse Event
Malfunction ·AESCULAP AG & CO. KG·Product code GEI·January 13, 2015

AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

BAYONET FORCEPS BIPOLAR IRRIGATING

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MARYLAND GSP.FORCEPS FEN.5/310MM HF CON.

FDA Adverse Event
Malfunction ·AESCULAP AG & CO. KG·Product code GEI·February 19, 2014

3012752-001 QPACE 1/P 10/B 50/

FDA Adverse Event
Malfunction ·COVIDIEN·Product code MKJ·November 25, 2013

AED PLUS

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·February 22, 2013

R SERIES DEFIBRILLATOR

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 2, 2011

LUMAX 340 DR-T

FDA Adverse Event
Malfunction ·BIOTRONIK GMBH AND CO.·Product code MRM·March 12, 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

Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024