624 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODULAR SYSTEM
FDA UDI
HI-TEC IMPLANTS LTD.·07290110728496·SLEEVE
Velara GCF 2T
FDA UDI
Philips Medical Systems DMC GmbH·00884838076150·X-ray control and HV generator
Velara GCF 2T
FDA UDI
Philips Medical Systems DMC GmbH·00884838088559·X-ray control and HV generator
CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
FDA Recall
Terminated
·Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code JAA·December 19, 2019
*
FDA Adverse Event
Malfunction
·BK MEDICAL SYSTEMS, INC.·Product code GCF·December 7, 2009
PROCTOSCOPE POWER TRANSFORMER
FDA Adverse Event
Malfunction
·WELCH ALLYN HOLDINGS INC·Product code GCF·December 20, 2007
5MM X 32CM, A-TRAC LAPAROSCOPIC GRASPER
FDA Adverse Event
Injury
·APPLIED MEDICAL RESOURCES·Product code GCF·November 14, 2001
WELCH ALLYN
FDA Adverse Event
Malfunction
·WELCH ALLYN·Product code GCF·September 11, 2012
AIRSEAL
FDA Adverse Event
Malfunction
·SURGIQUEST,INC.·Product code GCF·March 15, 2016
CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems Gmbh, DMC·February 26, 2020
TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL·Product code OAE·December 20, 2024
CONTINUOUS RENAL REPLACEMENT THERAPY(CRRT)
FDA Adverse Event
Death
·UNK·Product code KDI·October 8, 2025
COLONOVIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDF·December 28, 2023
SAF-GEL - WOUND DRESSING W/ ALGINATE
FDA Adverse Event
Injury
·ACCUPAC, INC·Product code NAE·September 30, 2013
DUODERM CGF DRESSING
FDA Adverse Event
Injury
·CONVATEC, INC·Product code NAD·September 30, 2013
AQUACEL HYDROFIBER WOUND DRESSING
FDA Adverse Event
Injury
·CONVATEC LIMITED·Product code FRO·September 30, 2013
UNNA FLEX ELEASTIC UNNA BOOT
FDA Adverse Event
Injury
·CONVATEC LIMITED·Product code FQM·September 30, 2013
CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
FDA Recall
Terminated
·Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code JAA·December 19, 2019
Injection Needle, REF: 25207
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code GCF·October 24, 2023
Proctoscope
FDA classification
FDA Class 2
·Proctoscope