18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5%
FDA 510(k)
FDA Unclassified
·Unknown
Aligned Medical Solutions
FDA UDI
Aligned Medical Solutions·B09800907910·Bayview Abdominoplasty Pack
NGB-012 Needle-guided Bracket/PLAS/VET
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904018454·
iCONNECT - AMPERE
FDA UDI
OSYPKA GmbH·04044508137048·The system cables are used for the connection o...
REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000)
FDA 510(k)
FDA Class 2
·Cardiovascular
HBS HEADLESS BONE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
TRIAGE TOX DRUG SCREEN PANEL
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code DIO·March 27, 2017
TRIAGE TOX DRUG SCREEN PANEL
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code DIO·May 23, 2017
TRIAGE TOX DRUG SCREEN PANEL
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code DIO·May 8, 2017
TRIAGE TOX DRUG SCREEN PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code DIO·October 4, 2019
TOTAL ASR FEM IMP SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·May 2, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 15, 2014
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·April 26, 2011
Bayview Abdominoplasty Pack, part number 009079-1
FDA Recall
Terminated
·Windstone Medical Packaging, Inc.·Product code FSY·January 11, 2017
Bayview Abdominoplasty Pack, part number 009079-1
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
Bayview Abdominoplasty Pack, Kit part number 009079-1 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Bayview Abdominoplasty Pack, Kit part number 009079-1 convenience custom kits used for general surgery in hospital operating room
FDA Recall
Terminated
·Windstone Medical Packaging, Inc.·Product code FSY·April 22, 2015