22 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Metal Custom Rx
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746103667·BRACKET MEDIUM TWIN MAX RIGHT CUSPID 022 TQ=-10...
V-CAS Catheter Advancement System
FDA UDI
Stereotaxis, Inc.·M58800100242210·The Vdrive with V-CAS Disposable is indicated f...
S57D DIGITAL OPERATING ROOM CAMERA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PSN HEMODIALYZER, MODELS PSN 170, PSN 210
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEFIBRILLATOR
FDA Adverse Event
Malfunction
·HEWLETT-PACKARD CO.·Product code LDD·June 10, 1994
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 30, 2026
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 30, 2026
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 30, 2026
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 30, 2026
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 30, 2026
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·March 13, 2013
EON IMPLANTABLE PULSE GENERATOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·January 28, 2011
SELUTE PICOTIP
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DTB·February 7, 2008
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 30, 2026
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 30, 2026
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 30, 2026
VERTEBRAL BODY STENT-LARGE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code NDN·May 24, 2021
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024