23 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CONDUIT Instruments
FDA 510(k)
FDA Class 2
·Orthopedic
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197132237·Foramenotomy Rongeur, curved upwards,40°
20 cm ...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197389396·Foramenotomy Rongeur, curved upwards,40°
20 cm ...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197132220·Foramenotomy Rongeur, curved upwards,40°
20 cm ...
VIDAS SARS-COV-2 IGG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code QKO·December 30, 2020
HARMONE-SCHWARZER EEG SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
IMESH TACKER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VIDAS SARS-COV-2 IGG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code QKO·November 17, 2020
VIDAS SARS-COV-2 IGG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code QKO·November 17, 2020
SIGN I.M. NAIL
FDA Adverse Event
Injury
·SURGICAL IMPLANT GENERATION NETWORK (SIGN)·Product code HSB·October 23, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 12, 2011
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 8, 2013
BD MICROLANCE¿ 3 NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·February 16, 2022
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·August 23, 2021
PIPELINE FLEX W/SHIELD TECHNOLOGY
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·February 21, 2022
BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015