14 results
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21ms
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Sources: EU EUDAMED, US FDA
EC-3870CILK, CONFOCAL VIDEO COLONOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809868265·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND CLOSED...
LIQUICHEK TDM CONTROL
FDA 510(k)
FDA Class 1
·Clinical Toxicology
BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK
FDA 510(k)
FDA Class 2
·General Hospital
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·April 17, 2023
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·April 18, 2023
12.4CM HEAVY DUTY LONG ATTCH
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·April 2, 2013
EASYTRAK 3
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWP·May 8, 2008
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·April 6, 2011
SILVERSOAKER CATHETER
FDA Adverse Event
Other
·I-FLOW CORP.·Product code BSO·September 29, 2010
PKG, 5MM SHAFT, NEEDLE HOLDER, STRAIGHT, 45CM, P/N 0250080588 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·December 18, 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
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024