17 results
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27ms
·
Sources: EU EUDAMED, US FDA
BABY BOARDS IV SUPPORT ASSEMBLY
FDA 510(k)
FDA Class 1
·General Hospital
Biopsy Handy
FDA UDI
SOMATEX Medical Technologies GmbH·04250195601902·
Barricade Coil System
FDA UDI
BALT USA LLC·00818053021336·Barricade Coil System (BCS) is intended for the...
3M™ Unitek™
FDA UDI
3M COMPANY·30605861027299·3M™ Unitek™ Stainless SteelFirst Primary Molar ...
Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746097188·DB BRACKET MASTER SERIES IBD MAND RIGHT/LEFT 1S...
CONLIN MOLAR BAND
FDA UDI
Ortho Arch Company Inc·D90990013414·MOLAR BAND CONLIN RX LR 30.5
Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.
FDA Enforcement
Class II
·Terminated·Neuro Kinetics, Inc.·September 9, 2015
XBraid TT
FDA UDI
RIVERPOINT MEDICAL, LLC·00840277401250·Suture Tape
Elite®
FDA UDI
Ortho Organizers, Inc.·00190707050795·.022 UL6 CV STD -14T 0A 14O
INTRAVENOUS POWER INJECTOR EXTENSION SET
FDA 510(k)
FDA Class 2
·General Hospital
Jimushi Sterile Urethral Catheter for single use
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MOBILE LINER ØINT 28 MM Ø40 MM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code LZO·October 21, 2022
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DTQ·May 1, 2014
6 SHOOTER SAEED MULTI-BAND LIGATOR
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code MND·October 22, 2010
TWINLOOP FLEX DISPOSABLE DRILL
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY PUERTO RICO·Product code HTW·December 27, 2012
SMR CEMENTLESS FINNED STEM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code HSD·October 26, 2023
SMR CONNECTOR SMALL STD
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWS·February 15, 2022