14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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High Performance Antimicrobial Gelling Fiber with Silver
FDA 510(k)
FDA Unclassified
·Unknown
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197492089·Distractor, large model
outspr...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197492072·Distractor, small model
closed...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197492065·Distractor, small model
outspr...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197492096·Distractor, large model
closed...
QLAB Advanced Quantification Software
FDA 510(k)
FDA Class 2
·Radiology
RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE STYLET
FDA 510(k)
FDA Class 2
·Cardiovascular
SMALL HEXAGONAL SCREWDRIVER 2.5MM WIDTH ACROSS FLATS
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HXX·May 29, 2019
SJM TRIFECTA VALVE
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LWR·November 16, 2023
PANAVIA (RESIN)
FDA Adverse Event
Injury
·Product code EBF·October 27, 2008
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·August 12, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 8, 2013
NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code BSP·August 5, 2025
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