13 results · 20ms · Sources: EU EUDAMED, US FDA

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SAS RSV TEST

FDA 510(k)
FDA Class 1 ·Microbiology

CD HORIZON® Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074025018·BONE SCREW 7022845 20 DEG ILC 8.5X45 SS

Specials

FDA UDI
Seaspine Orthopedics Corporation·10889981159344·Solid Tap, Sharp, 4.5mm

Logical Dual Mobility Poly Insert

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215112455·

SIMPLICITY SOFT QD MICRO INFUSION SET

FDA 510(k)
FDA Class 2 ·General Hospital

PAFLUFOCON C AND E DAILY CONTACT LENS

FDA 510(k)
FDA Class 2 ·Ophthalmic

D/M ONE-SIDED CABLE TENSIONER

FDA Adverse Event
Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LXH·March 27, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code MDS·February 16, 2011

BRAVO

FDA Adverse Event
Malfunction ·ARIZONA DEVICE MANUFACTURING·Product code FFT·March 28, 2008

MANTIS REDUX BLOCKER

FDA Adverse Event
Malfunction ·STRYKER SPINE-US·Product code NKB·November 27, 2019

The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

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

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 Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

FDA Enforcement
Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014