15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Primelase Excellence
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EarQ
FDA UDI
Oticon A/S·05707131354655·G30 S, MINIRITE T 312 2.4G C093 EARQ
7400 RV2 MASK
FDA UDI
HANS RUDOLPH, INC.·00874750002290·LARGE 7400 W/SMC ADPT & QR HG
24M - Duke Energy FA/BBP
FDA UDI
Certified Safety Manufacturing, Inc.·00766588015149·24M - Duke Energy FA/BBP
16PW - Loggers - Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588015040·16PW - Loggers - Poly White
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383512336·"An absorbent paper points is an endodontic pap...
3.5 MM LAPAROSCOPE (LG100, LG103)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COPC BAND
FDA 510(k)
FDA Class 2
·Neurology
COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
FDA Adverse Event
Injury
·Product code DTK·August 23, 2016
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SWINFORD·Product code KDI·October 27, 2014
REVEAL DX
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DSI·August 11, 2011
SYNCHROMED II
FDA Adverse Event
Death
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·March 20, 2018
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
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