16 results · 21ms · 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.

PIEZOSURGERY 3; OSSTEM PIEZO

FDA 510(k)
FDA Class 2 ·Dental

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450249765·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450261408·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450252963·

REGAL MOTOTRIZED 3 WHEELED VEHICLE

FDA 510(k)
FDA Class 2 ·Physical Medicine

ULTRA VUE 55/P & C (METHAFILCON A) SOFT (MULTIFOCAL, SPHERICAL, & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILIT

FDA 510(k)
FDA Class 2 ·Ophthalmic

ITREL 3

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 15, 2016

PASSPORT V MONITOR

FDA Adverse Event
Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

HP MBT CEM KEEL PUNCH SZ 4-7

FDA Adverse Event
Malfunction ·1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC·Product code LXH·September 16, 2014

ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORP.·Product code LZG·April 20, 2011

ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code DQY·May 7, 2019

NEB100

FDA Adverse Event
Malfunction ·SUNSET HEALTHCARE SOLUTIONS·Product code CAF·January 29, 2019

ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code DQY·July 14, 2017

Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.

FDA Enforcement
Class II ·Terminated·Merit Medical Systems, Inc.·November 30, 2016

Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

FDA Enforcement
Class I ·Terminated·Dexcom Inc·April 20, 2016

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