15 results · 24ms · Sources: EU EUDAMED, US FDA

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ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System

FDA 510(k)
FDA Class 2 ·Orthopedic

OsteoMed

FDA UDI
OSTEOMED LLC·00842528103142·7.0 x 120mm Cann Hdless Screw, 32mm Thd

SILICONE MCP

FDA UDI
Stryker GmbH·00886385021829·Metacarpal Broach, Size 00

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197074995·COLLIN abdominal retractor

OsteoMed

FDA UDI
OSTEOMED LLC·00842528107508·7.0 x 120mm Hdls Screw 32Thd Sterile 2Pk

PREVENA INCISION MANAGEMENT SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE

FDA 510(k)
FDA Class 1 ·General Hospital

BELIFU

FDA Adverse Event
Injury ·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020

PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM

FDA Adverse Event
Injury ·KINETIC CONCEPTS, INC.·Product code OMP·July 19, 2019

HEARTSTART MRX - EMS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 6, 2013

HEARTSTART MRX

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·June 22, 2011

ACCU-CHEK COMPACT TEST DRUM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 15, 2008

FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth

FDA Enforcement
Class II ·Ongoing·Envisiontec US Llc·February 23, 2022

FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth

FDA Enforcement
Class II ·Ongoing·Envisiontec US Llc·February 23, 2022

CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024