17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ART-PLAN
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743724·ACHIMED ACHILLES SUPP SAND III
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776162375·Standard 8mm 150mm sleeve w/ removable sheath &...
BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BACT/ALERT FA CULTURE BOTTLE
FDA 510(k)
FDA Class 1
·Microbiology
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·October 30, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 23, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 11, 2013
TPRLC XR T1 PPS 13X146MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·April 29, 2025
TPRLC XR MP T1 PPS 13X111MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·April 29, 2025
TPRLC XR MP T1 PPS 14X113MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·April 29, 2025
TPRLC 133 T1 PPS SO 16X152MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·April 29, 2025
TPRLC 133 T1 PPS SO 17X154MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·April 29, 2025
TPRLC 133 MP TYPE1 PPS SO 16.0
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·April 29, 2025
TPRLC XR MP T1 PPS 16X117MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·April 29, 2025
TPRLC XR FP TYPE1 PPS 7X134MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·April 29, 2025
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018