19 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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MAYFIELD MR/X-RAY SKULL CLAMP
FDA 510(k)
FDA Class 2
·Neurology
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489105619·PowerChem Neoprene Exam Gloves, Extra Small
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810057371905·Shoulder Pad Left Short Trumpf
Medzah Aluminum Crutches Small
FDA UDI
Medzah Industries·00860009370609·
AMT THERAPEUTIC TABLE, MODEL 748AMT
FDA 510(k)
FDA Class 2
·Physical Medicine
RAMBLER
FDA 510(k)
FDA Class 2
·Physical Medicine
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523153541·Tesera X Cage, 40mm x 18mm x 12mm, Convex 7°
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523153527·Tesera X Cage, 40mm x 18mm x 10mm, Convex 7°
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523153589·Tesera X Cage, 40mm x 18mm x 16mm, Convex 7°
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523153503·Tesera X Cage, 40mm x 18mm x 8mm, Convex 7°
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523153602·Tesera X Cage, 40mm x 18mm x 18mm, Convex 7°
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523153565·Tesera X Cage, 40mm x 18mm x 14mm, Convex 7°
PREFYX PPS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code FTL·April 26, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·September 11, 2014
DBS LEAD
FDA Adverse Event
Malfunction
·MPROC, VILLALBA·Product code MHY·April 22, 2011
BD SAF-T-INTIMA Y ADP PNK 20GA X 1.0IN
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·July 8, 2025
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
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025