18 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K1430220·Rod Cutter, Table Top
BioHorizons Tapered Internal Implants
FDA 510(k)
FDA Class 2
·Dental
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613038595·Antrum Curette, 7mm x 11mm Oval Cup, Slightly C...
LEONE SPA
FDA UDI
LEONE SPA·08033707011804·CALIBRA 1ST MOL BANDS W/G8025-03 n.UL 22
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1430210·Rod Template, 500mm
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1430200·Rod Template, 250mm
KIM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STRYKER FLEXIBLE CYSTONEPHROSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MALE LL ADAPTOR
FDA Adverse Event
Malfunction
·Product code FPA·May 17, 2021
SEC 20DP, TEXIUM & HANGER V/NV
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·March 31, 2021
BD LUER-LOCK¿ MALE ADAPTER
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·December 30, 2022
SEC 20DP, TEXIUM & HANGER V/NV
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·February 11, 2021
PELVICOL ACELLULAR COLLAGEN MATRIX 4X7 CM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE·Product code FTL·May 24, 2013
PARASIGM REAL TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·September 27, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 28, 2011
PKG, PENNINGTON FORCEPS, P/N 0250080242. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
PCEA ASV YELLOW MICROBORE
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·August 10, 2020
GMK-HINGE FIXED TIBIAL INSERT SIZE 4/12MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·December 4, 2019