18 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/ PROTEIN CONTENT LABELING CLAIM 50 MCG OR LES
FDA 510(k)
FDA Class 1
·General Hospital
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526780750·LEVAMED ACTIVE ANKLE SUP SLVR L III
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033266748·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033266724·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033266700·
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0112230·Tap, 5.50mm, Cannulated, Fixed Sleeve
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033266731·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0112030·Tap, 5.5 mm
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033266755·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033266717·
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0112330·Tap, 5.50mm, Fixed Sleeve
MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNCHRON LX 20 PRO CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·June 8, 2011
AMPLATZ SUPER STIFF GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DQX·March 19, 2013
ASR ACETABULAR CUPS 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 4, 2011
ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT OTW
FDA Adverse Event
Malfunction
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·March 11, 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