17 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT
FDA 510(k)
FDA Class 2
·Dental
12 x 60mm Anodized SI Implant
FDA UDI
Osteocentric Technologies, Inc.·00810097800021·12 x 60mm Anodized SI Implant
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659174269·6.5 Cancellous Bone Screw, hex, _x000D_...
Integrity-SI Fusion System
FDA UDI
Lincotek Medical LLC·B57112521012060D0·12 x 60 mm Anodized SI Implant
CorticaLINK
FDA UDI
LINKSPINE, INC.·00817329020349·5.0mm CoCr Rod: 60mm Curved
6.5 Cancellous Bone Screw, hex, St.Steel, L 60 mm
FDA UDI
mahe medical gmbh·EMAH00100120600·6.5 Cancellous Bone Screw, hex,
St.Ste...
NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RITA STARBURST XLI ELECTROSURGICAL DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 15, 2025
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 28, 2020
VAPR VUE WIRELESS FOOTSWITCH
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code GEI·November 20, 2020
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 14, 2007
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE AG·Product code LZG·March 20, 2013
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·February 28, 2011
uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.
FDA Enforcement
Class II
·Terminated·Ulrich Medical USA Inc·May 3, 2017
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system
FDA Enforcement
Class II
·Ongoing·Intuitive Surgical, Inc.·June 10, 2026
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012