19 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE
FDA 510(k)
FDA Class 1
·General Hospital
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040008416·Zirlux 16+ B3D 89x17x16
ACUFEX
FDA UDI
Smith & Nephew, Inc.·03596010024091·DUCKLING PUNCH BASKET UPSWEPT LOOP HANDLE
Tempus Pro
FDA UDI
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED·05060472440136·Invasive Pressure Adaptor 2 Channel - Utah Delt...
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033350447·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033350430·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033350454·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033350478·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033350461·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033350423·
M2376A DEVICELINK SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
JBC OPAQUE AND GLITTER
FDA 510(k)
FDA Class 2
·Dental
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 14, 2007
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·March 20, 2013
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·February 28, 2011
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
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025