19 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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NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT
FDA 510(k)
FDA Class 2
·Orthopedic
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5821109250·FORCEPS, DRESSING, DENTAL
CHS
FDA UDI
Smith & Nephew, Inc.·03596010036612·ADJUSTABLE ANGLE GUIDE FOR 3.2MM
...
Copper Ni-Ti - Archwire
FDA UDI
ORMCO CORPORATION·00889989028706·COPPER NITI 35 BAF 19X025LO SM PK10
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16710031109250·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311109250·
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306819544·Posterior Blade 1 x 4.5"
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K1102250·Tray, Base, 2.25", Universal
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K1104250·Tray, Base, 4.25", Arcamed
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K1104250·Tray, 4.25 Inch Base
ASCENSION ANKLE FUSION NAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E
FDA 510(k)
FDA Class 2
·Anesthesiology
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197541725·Ferreira Style Breast Retractor
110x25...
LAMITRODE TRIPOLE 16C
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 8, 2013
CBK
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·March 16, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 14, 2008
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