16 results · 23ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

SUMMIT OCT SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

OsteoMed

FDA UDI
OSTEOMED LLC·00845694000468·1.2mm x 3mm Screw

SOAR Retractor System

FDA UDI
SPINEOLOGY INC.·M7403041203·12mm x 30mm Portal Tube

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0112030·Tap, 5.5 mm

OsteoMed

FDA UDI
OSTEOMED LLC·00845694028851·1.2mm x 3mm Screw, Sterile

OsteoMed

FDA UDI
OSTEOMED LLC·00845694054379·1.2 x 3mm Screw Sterile Qty 10

OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT

FDA 510(k)
FDA Class 2 ·Radiology

ABX MICROS 60 HEMATOLOGY ANALYZER

FDA 510(k)
FDA Class 2 ·Hematology

ADVIA CENTAUR XP AFP

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LOJ·June 4, 2019

ADVIA CENTAUR XP AFP

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LOJ·June 4, 2019

S8 AUTOSET VANTAGE -AMERICAS

FDA Adverse Event
Malfunction ·RESMED LTD.·Product code BZD·April 2, 2013

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·March 29, 2011

ACCU-CHEK COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS CORP.·Product code LFR·May 9, 2008

VENTED AUTOFEED HUMIDIFICATION CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·February 14, 2012

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

The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018