15 results · 21ms · Sources: EU EUDAMED, US FDA

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PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496071563·STRIPE GAME FENICE, SIZE S, NERO, GRADUATED COM...

Sklar

FDA UDI
SKLAR CORPORATION·30649111147214·RUBBER JAWS FOR YOUNG FCP PK/2

NA

FDA UDI
STERILMED, INC.·10888551007658·SAW BLADE OSCILLATING LARGE BONE

POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM

FDA 510(k)
FDA Class 1 ·General Hospital

SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

BRASSELER SAW BLADE

FDA Adverse Event
Injury ·BRASSELER USA·Product code GFA·October 21, 2012

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 22, 2013

ISE INDIRECT NA+ FOR GEN.2

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JGS·April 28, 2011

R-I-FLOW PAIN BUSTER

FDA Adverse Event
Injury ·R-I-FLOW CORPORATION·Product code MEB·July 9, 2008

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

Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022