20 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO
FDA 510(k)
FDA Class 2
·Orthopedic
MIRABAY
FDA UDI
Mirabay Orthodontics Corp.·05065025111624·KLEOS 2 PSL METAL STANDARD TORQUE 022 LL3 PK5
LEONE SPA
FDA UDI
LEONE SPA·08033707010067·CALIBRA 1ST MOLAR BANDS n.UL 33
ELMED
FDA UDI
ELMED INCORPORATED·00842180159730·ALLIGATOR GRASPING FORCEPS, SEMI-RIGID 3 FR DIA...
GESCO
FDA Adverse Event
Malfunction
·UTAH MEDICAL PRODUCTS·Product code FOS·September 19, 2014
LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX
FDA 510(k)
FDA Class 2
·Orthopedic
VERCISE GENUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code MHY·December 11, 2024
V.A.C. FREEDOM THERAPY SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·February 15, 2021
MOLIFT SMART
FDA Adverse Event
Other
·ETAC AS (DIV ETAC SUPPLY GJOEVIK, NORWAY)·Product code FSA·May 22, 2013
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - GUANGZHOU·Product code KDI·September 30, 2014
SOLA 500/700
FDA Adverse Event
Malfunction
·DRAGER MEDICAL GMBH·Product code FTD·May 4, 2011
Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.
FDA Enforcement
Class II
·Terminated·Atom Medical Corporation·July 18, 2012
Incu i (Atom Infant Incubator Model 101) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.
FDA Recall
Terminated
·Atom Medical Corporation 3-18-15 Hongo Bunkyo-Ku Japan·Product code FMZ·August 23, 2011
Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.
FDA Recall
Terminated
·Atom Medical Corporation 3-18-15 Hongo Bunkyo-Ku Japan·Product code FMZ·May 1, 2012
Rabee Incu i (Atom Infant Incubator Model 102) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.
FDA Recall
Terminated
·Atom Medical Corporation 3-18-15 Hongo Bunkyo-Ku Japan·Product code FMZ·August 23, 2011
Infa Warmer i (Atom Infant Warmer Model 103) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: A warmer for infants.
FDA Recall
Terminated
·Atom Medical Corporation 3-18-15 Hongo Bunkyo-Ku Japan·Product code FMZ·August 23, 2011
Dual Incu i (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: A combination incubator and warmer for infants.
FDA Recall
Terminated
·Atom Medical Corporation 3-18-15 Hongo Bunkyo-Ku Japan·Product code FMZ·August 23, 2011
SmartPath to dStream for 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22-118 ZIMB-22-128 ZIMB-22-70 ZIMB-22-84 ZIMB-22-98 ZIMB-24-108 ZIMB-24-118 ZIMB-24-128 ZIMB-24-70 ZIMB-24-84 ZIMB-24-98 ZIMB-26-108 ZIMB-26-118 ZIMB-26-128 ZIMB-26-70 ZIMB-26-84 ZIMB-26-98 ZIMB-28-108 ZIMB-28-118 ZIMB-28-128 ZIMB-28-70 ZIMB-28-84 ZIMB-28-98 ZIMB-30-108 ZIMB-30-118 ZIMB-30-128 ZIMB-30-70 ZIMB-30-84 ZIMB-30-98 ZIMB-32-108 ZIMB-32-108 ZIMB-32-118 ZIMB-32-128 ZIMB-32-70 ZIMB-32-84 ZIMB-32-98 ZIMB-36-108 ZIMB-36-118 ZIMB-36-128 ZIMB-36-84 ZIMB-36-98
FDA Enforcement
Class II
·Terminated·Cook Inc.·September 23, 2020