15 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TINNITUS SOUND GENERATOR MODULE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ZEUS-O
FDA UDI
SPINAL ELEMENTS·00840916122256·Zeus-O Implant, 11 x 09 x 32mm
Copper Ni-Ti - Archwire
FDA UDI
ORMCO CORPORATION·00889989028744·COPPER NITI 35 BAF 16X022LO LG PK10
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587P11093270·11mm PLIF Implant 9mm Wide 32mm Length, 7 deg L...
Posted Stainless Steel Archwire
FDA UDI
Ortho Arch Company Inc·D90911093213·.019 X .025 POSTED SS RIGHT FORM WIRES 32MM (10)
MYSTIQUE® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110532101·MYSTIQUE® MB RT RX 022 U 5-5/L3-3 CS HK
MUSE CARDIOLOGY INFORMATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
INCLUSIVE MINI IMPLANT
FDA 510(k)
FDA Class 2
·Dental
EON
FDA Adverse Event
Injury
·ST. JUDE MEDICAL- NEUROMODULATION·Product code LGW·May 8, 2013
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014
ENDOPROBE, 20G TAPERED
FDA Adverse Event
Malfunction
·IRIDEX CORP.·Product code GEX·April 1, 2011
Absorbable Collagen Sponge Provided As Intermediate to Another Company
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013
cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cobas¿ PCR media 100T IVD cobas¿ PCR Female Swab Kit 100 PKT JPN-IVD Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 The cobas¿¿ PCR media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens and is contained in the cobas¿¿ PCR Female Swab Kit, cobas¿¿ PCR Urine kit, and cobas¿¿ PCR media 100 T kit. -The cobas¿¿ PCR Urine Sample Kit is used to collect and transport urine specimens. Use this collection kit only with the cobas¿¿ CT/NG Test. - The cobas¿¿ PCR Female Swab Sample Kit is used to collect and transport endocervical and vaginal swab specimens. Use this collection kit only with the cobas¿¿ CT/NG Test NOTE: This collection kit should not be used for collection of female urine specimens. o For endocervical swab specimens, collections are to be performed by a clinician. o For vaginal swab specimens, collections are to be performed by a clinician or by the patient (self-collection) -In US labeling, it indicates Self collection in a clinical setting. - In ex-US labeling, it indicates Clinician Instructed Self- Collection and Ensure the patient has read and understood the following self-collection instructions before providing a collection kit. - In some countries (e.g., UK), the sample collection kit is provided as self-collection for home / personal use, which may not be used in a controlled clinical setting and it is unknown if any instructions are provided. - The cobas¿¿ PCR media kit is used to stabilize and transport urine specimens. Use this kit only with the cobas¿¿ CT/NG Test.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·March 5, 2014
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) 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
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024