15 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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DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MSB Reusable Instruments
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000242510·GRAFT DELIVERY 6061020 LOADING PLATFORM
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00610201·
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70610201·Mini Sprint-Brackets 5-5 Roth .022" 1000 Brackets
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482051986·Symmetry® Forceps, Tissue, 2x3 Teeth, 8 in
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0160200·T-Handle, T20 Dominoes Cap Starter
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0160200·Tamp, Straight
DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
8100 VITAL SIGNS MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·September 8, 2015
LEAD EXTRACTION EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·September 9, 2015
ADVANTA BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 26, 2013
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 18, 2011
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCUAL
FDA Adverse Event
Malfunction
·STAAR SURGICAL·Product code HQL·June 13, 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