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

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PIPER

FDA 510(k)
FDA Class 2 ·Radiology

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·H65810012951·REAMERS 25MM

Preat

FDA UDI
Preat Corporation·00842092183892·ASC Straumann? TL RN-compatible Non-Engaging Ti...

artVeneer life

FDA UDI
Merz Dental GmbH·D7092001295·artVeneer life lower anteriors, UIM, B4

Palisade Pedicular Fixation System

FDA UDI
SPINEOLOGY INC.·M7401001295·QuikStep Carrier Wrench

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197541107·Breats Fascial Spreader diamond shaped 2 9mm bl...

OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130

FDA 510(k)
FDA Class 2 ·Anesthesiology

ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

PREMIUM PLUS CEEA

FDA Adverse Event
Malfunction ·US SURGICAL PUERTO RICO·Product code GDW·April 19, 2018

SYRINGE 30ML LL

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·July 23, 2020

SEXTANT SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code MCV·October 29, 2009

12/14 ARTICUL 40MM M SPEC-2

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·March 13, 2013

TANDEM T:SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·July 21, 2014

LUMINEX 3 BILIARY STENT

FDA Adverse Event
Malfunction ·ANGIOMED GMBH & CO., MEDIZINTECHNIK·Product code FGE·February 19, 2008

SPINNING SPIROS CLOSED MALE LUER, RED CAP

FDA Adverse Event
Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·August 3, 2020

PREMIUM UROLOGY PACK - CUSTOMED- (1) LITHOTOMY DRAPE W/POUCH ANESTH. (2) ABSORBENT TOWELS UF (1) MAYO STAND COVER REINFORCED UF (1) URINARY DRAINAGE BAG 2000ml ANTI-REFLUX UF (1) GOWN SURG. REINFORCED LARGE T/WRAP (1) UTILITY BOWL 32 OZ. (1) TUBE SUCTION CONNEC. W' X 12' UF (1) TABLE COVER REINFORCED 50" X 90" UF (1) TUR Y SET 81 "2.1M REGULAR CLAM ST. (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA Enforcement
Class I ·Terminated·Customed, Inc·September 10, 2014

Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

FDA Enforcement
Class II ·Terminated·Unomedical As·July 1, 2015

ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013

Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

FDA Enforcement
Class II ·Ongoing·Covidien·August 28, 2024