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