23 results · 32ms · Sources: EU EUDAMED, 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