12 results · 19ms · Sources: EU EUDAMED, US FDA

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PINNACLE REVISION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033338·Baltic Denture System BDLoad BDLoad Mw7 PLSEbi...

INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP300, COC150, THC

FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918000719·INSTANT-VIEW Multi-Drugs of Abuse Urine Test AM...

PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2

FDA 510(k)
FDA Class 2 ·Cardiovascular

BIO-EYE II ORBITAL IMPLANT

FDA 510(k)
FDA Class 2 ·Ophthalmic

HEAD START XL

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 1, 2013

GOBED II

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·March 22, 2011

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 25, 2014

POLYMOBIL PLUS

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE GMBH·Product code IZL·July 27, 2023

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

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021