13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VECTORS TEMPORARY ANCHORAGE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Mini Sprint ®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70612301·Mini Sprint II Brackets FACE Evolution II Syste...
Kalitec
FDA UDI
Kalitec Direct LLC·B07319K0162300·Bone Funnel
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0112300·Tap, 8.5mm Cortical, SNI1
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197539111·Jacobson Micro Scissors
14mm l...
HERO
FDA 510(k)
FDA Class 2
·Cardiovascular
GE PROPELLER IMAGING OPTION FOR MRI
FDA 510(k)
FDA Class 2
·Radiology
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 16, 2013
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 19, 2008
MESH - VENTRALEX
FDA Adverse Event
Injury
·DAVOL INC.·Product code FTL·April 11, 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
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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