11 results · 19ms · Sources: EU EUDAMED, 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