31 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DISPOSABLE ENDOSCOPIC CANNULA
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550124·GENUMEDI PT KNEE SUP SILVER L EW III
Accent Buccal Tube
FDA UDI
ORMCO CORPORATION·00889989053814·ORTHOS ACCENT LSM 5SGL WDX -10TX22 L
OsteoMed
FDA UDI
OSTEOMED LLC·00845694003995·Fracture Plate, 6 Hole DCP, 47mm
MHLX7EC TRANSDUCER
FDA 510(k)
FDA Class 2
·Radiology
LUMANOSITY CELEBRITY, MODEL 204
FDA 510(k)
FDA Class 2
·Physical Medicine
HISTOACRYL FLEXIBLE PACK 5
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code MPN·December 3, 2019
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·February 22, 2023
CANNULA
FDA Adverse Event
Malfunction
·MENTOR WORLDWIDE LLC·Product code CAN·August 25, 2017
ROD, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019
5.5 TI CANNULATED TRANSLATION SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code DTB·October 3, 2014
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·May 31, 2013
COLLEAGUE PRE-P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 25, 2011
POLARIS SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·January 8, 2020
CATHETER MOUNT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZO·August 6, 2014
PEDICLE SCREW UNSPECIFIED
FDA Adverse Event
Malfunction
·ZIMMER BIOMET SPINE INC.·Product code NKB·April 20, 2021
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
PEDICLE SCREW UNSPECIFIED
FDA Adverse Event
Malfunction
·ZIMMER BIOMET SPINE INC.·Product code NKB·April 20, 2021
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025