17 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LOGIQ E9
FDA 510(k)
FDA Class 2
·Radiology
Corin BiPolar-i
FDA UDI
CORIN LTD·05056139234354·Corin BiPolar-i Ø43/22mm
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5821109430·FORCEPS, DRESSING, DENTAL
Copper Ni-Ti - Archwire
FDA UDI
ORMCO CORPORATION·00889989028805·COPPER NITI 40 BAF17X25LO SM PK10
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450459287·
ACCUCATH ACE INTRAVASCULAR CATHETER
FDA Adverse Event
Malfunction
·C. R. BARD, INC.·Product code FOZ·July 1, 2021
T-Handle AO-coupling
FDA UDI
Spierings Orthopaedics B.V.·08720256027287·
INVADER FACTOR II
FDA 510(k)
FDA Class 2
·Hematology
SYNTHES STERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LOGIC TIBIA PS MOD INSRT SZ 5 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 1, 2022
ELITE PLUS SZ 1 ROUNDBACK
FDA Adverse Event
Injury
·8010379 DEPUY INTL., LTD.·Product code KWY·May 14, 2013
RUSCH LITE SLIM MAC 3 BLADE
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code GEI·April 15, 2011
STERI-CATH CLOSED VENTILATION SYSTEM
FDA Adverse Event
Injury
·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code BSY·August 4, 2008
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 29, 2019
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
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 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