23 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GYNECARE TVT ABBREVO CONTINENCE SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GYNECARE TVT-ABBREVO MINI LCM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·November 30, 2021
Premier
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00856402006306·Decan Stopper Size 5 Closure Full
AIM™FEMORAL NAIL
FDA UDI
Biomet Orthopedics, LLC·00887868003103·
Copper Ni-Ti - Archwire
FDA UDI
ORMCO CORPORATION·00889989027495·COPPER NITI 35 BAF 21X25UPLG PK10
SONTEC V.A.T.S. ALLIS DEBAKEY CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896003927·SONTEC V.A.T.S. ALLIS DEBAKEY CLAMP CURVED LEFT
SONTEC V.A.T.S. ALLIS DEBAKEY CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921009360·SONTEC V.A.T.S. ALLIS DEBAKEY CLAMP CURVED LEFT
ZEUS-O
FDA UDI
SPINAL ELEMENTS·00840916122218·Zeus-O Implant, 10 x 9 x 36mm
LEONE SPA
FDA UDI
LEONE SPA·08033707002826·COIL SPRINGS MEMORIA 036/009 OPEN
T2 SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code MQP·December 11, 2018
VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 25, 2012
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 3, 2024
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 8, 2013
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 19, 2014
TRANSENTERIX
FDA Adverse Event
Injury
·TRANSENTERIX, INC.·Product code LTI·May 18, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·April 14, 2022
INTERGRATED APD SET
FDA Adverse Event
Malfunction
·VANTIVE US HEALTHCARE LLC·Product code FKX·April 4, 2025
Cleaning probe included as an accessory to aspirators that are sterile packed single use disposable accessories to the GE InstaTrak 3500 Plus x-ray system. Probes are packaged and shipped together with the following aspirators: Straight Aspirator - 1000370-NAV, 7 French Aspirator - 100936, Keane - Moses Extended Straight Aspirator - 1000748, 15 degree aspirator - 1003895, Fried 45 Degree Aspirator - 1000541, Kuhn 90 degree Aspirator - 1000543-NAV.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code LLZ·May 18, 2007