13 results · 24ms · 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.

HEATMARKER TIME TEMPERATURE INDICATOR

FDA 510(k)
FDA Class 2 ·General Hospital

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496063759·SOCKS FOR YOU FREEDOM EASY, SIZE XL, BORDEAUX, ...

AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR

FDA 510(k)
FDA Class 2 ·Neurology

MSS-28CS-301/701 NEEDLESCOPE

FDA 510(k)
FDA Class 2 ·Neurology

2.0MM DRILL BIT WITH 14MM STOPQC

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code OVE·April 17, 2013

ACCU-CHEK COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 19, 2008

SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

FDA Adverse Event
Injury ·STAAR SURGICAL COMPANY·Product code HQL·April 14, 2011

DIMENSION VISTA®

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code MMI·August 28, 2018

PHENOM CATHETER

FDA Adverse Event
Malfunction ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code QJP·April 24, 2026

PIPELINE FLEX W/SHIELD TECHNOLOGY

FDA Adverse Event
Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·April 24, 2026

Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusion Set, Comfort, 23", STD 5/6; Comfort 13mm, 43" Hosp 10; Infusion Set, Comfort 43", STD 5/5; Infusion Set, Comfort Short, 13mm x 23"; Infusion Set, Comfort Short, 13mm x 32"; Infusion Set, Comfort, 17mm x 32"' Infusion Set, Comfort Short, 13mm x 43"; Infusion Set, Comfort, 17mm x 43" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

FDA Enforcement
Class II ·Terminated·Unomedical As·November 9, 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

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015