11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TITANIUM/STAINLESS STEEL DENTAL IMPLANT DRILL COMP
FDA 510(k)
FDA Class 2
·Dental
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112939·CORNEAL TREPHINE BLADE8.0MM
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515227668·McGee Mini Fcps, str, serr, 4mm jaws
Elite®
FDA UDI
Ortho Organizers, Inc.·00190707051990·.022 L6L DBT/NC -25T 5 OFF
S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE
FDA 510(k)
FDA Class 2
·Cardiovascular
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM
FDA Adverse Event
Injury
·STRYKER TRAUMA KIEL·Product code HSB·June 30, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 8, 2013
LCS COMPLETE FEM CEM L STD
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code MBH·November 15, 2010
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
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013