27 results · 23ms · Sources: EU EUDAMED, US FDA

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SOMATOM DEFINITION AS

FDA 510(k)
FDA Class 2 ·Radiology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814800·GENUMEDI EXTRA WIDE SILVER SIZE VII

PARALLEL WIRE EXTRACTION PLIERS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896051560·PARALLEL WIRE EXTRACTION PLIERS WITH TUNGSTEN C...

PMT CORPORATION - STEREOTACTIC

FDA UDI
PMT CORPORATION·00650551003946·REMOVAL TOOL FOR DEPTHALON ANCHOR BOLTS FOR 2.7...

REGAIN DESKTOP

FDA 510(k)
FDA Class 2 ·Neurology

ELI 230 ELECTROCARDIOGRAPH

FDA 510(k)
FDA Class 2 ·Cardiovascular

T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OZO·July 10, 2020

GALAXY G3 MINI 1MM X 3CM

FDA Adverse Event
Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·May 21, 2020

ACCU-CHEK SPIRIT COMBO

FDA Adverse Event
Injury ·ROCHE DIABETES CARE AG·Product code LZG·May 9, 2013

CONCORDE BULLET CAGE

FDA Adverse Event
Malfunction ·DEPUY SYNTHES SPINE·Product code MQP·September 19, 2014

COULTER® LH 500 HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code GKZ·May 25, 2011

OT ULTRAMINI METER

FDA Adverse Event
Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 2, 2013

SYRINGE 5ML EMERALD BNS

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·April 30, 2019

ADVIA CENTAUR HIV 1/O/2 ENAHNCED (EHIV) ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·March 3, 2014

Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

FDA Enforcement
Class II ·Terminated·Teleflex Medical·July 16, 2014

The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: This product provides the ability to position and hold a patient head while the patient is in the prone, supine, lateral or park-bench and sitting positions. It is intended to be used during diagnostic examinations or surgical procedures where a rigid support between the surgical table and a headrest or skull clamp is necessary and positional freedom is required.

FDA Enforcement
Class II ·Terminated·Integra LifeSciences Corporation·February 18, 2015

Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·November 6, 2024

Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

dS Breast 7ch 3.0T

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·December 4, 2024

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