20 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MAYFIELD INFINITY SKULL CLAMP
FDA 510(k)
FDA Class 2
·Neurology
N/A
FDA UDI
GEORGE TIEMANN & CO.·B58210514400·INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Q-RAD System
FDA UDI
CARESTREAM HEALTH, INC.·60889971051448·Q-RAD SYSTEM/QGV-40-2-R10-T080
LoFric®
FDA UDI
Wellspect AB·07392532131738·Single Use Urinary Catheter LoFric Coudé 16" 14FR
LoFric®
FDA UDI
Wellspect AB·07333387040042·Single Use Urinary Catheter LoFric Coudé 16" 14FR
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR20514401·Titanol S Spee-arches max. .016"x.016"
Mini Telemetry System
FDA UDI
WIPRO GE HEALTHCARE PRIVATE LIMITED·00840682117128·
Mini Telemetry System
FDA UDI
WIPRO GE HEALTHCARE PRIVATE LIMITED·00840682117067·
Mini Telemetry System
FDA UDI
WIPRO GE HEALTHCARE PRIVATE LIMITED·00840682117012·
Mini Telemetry System
FDA UDI
WIPRO GE HEALTHCARE PRIVATE LIMITED·00840682117166·
BONESOURCE HAC
FDA 510(k)
FDA Class 2
·Neurology
NEXTSTITCH CARDIOVASCULAR VALVE SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981173357·L Con, Side-Loading, L, 8mm, 440mm
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·August 7, 2018
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·April 10, 2013
ACAT 1 IAB PUMP ASSEMBLY
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·May 21, 2008
OEM STRETCHER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·April 4, 2011
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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 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