23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
FOOT SWITCH ASSEMBLY FOR ROSI
FDA UDI
VASCULAR TECHNOLOGY, INCORPORATED·00817122020416·Part Number 200795, FOOT SWITCH ASSEMBLY FOR ROSI
3D
FDA UDI
Rmo, Inc.·00885797100191·3D QUADACTION MAN 11 ASST OF 4
Waterlase Laser Tips
FDA UDI
Biolase, Inc.·00647529000731·An anterior tip kit containing 2 single-use RFT...
N/A
FDA UDI
STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825003753·Steerable Diagnostic EP Catheter , LARGE 4.0, 8...
N/A
FDA UDI
INNOVATIVE HEALTH LLC·10841898121371·EP XT Steerable Diagnostic EP Catheter, 6F
JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING
FDA 510(k)
FDA Class 2
·Orthopedic
RIGID GAS PERMEABLE CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
IM REAMER SHAFT, AO FITTING, DOVETAIL 8X885MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·May 13, 2011
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
SYNFIX LR
FDA Adverse Event
Injury
·DEPUY-SYNTHES·Product code OVD·November 16, 2017
TENSION FREE VAGINAL TAPE - SECUR UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code PAH·December 7, 2017
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 24, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·July 2, 2013
PATIENT INTERFACE NIM4CPB1 NIM 4.0
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GWF·October 28, 2025
Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - 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
STIMULATOR, ELECTRICAL, EVOKED RESPONSE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GWF·July 31, 2023
NIM 4.0 CONSOLE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GWF·September 5, 2025
NIM 4.0 CONSOLE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GWF·August 2, 2024