19 results · 29ms · Sources: EU EUDAMED, 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