14 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GOAT ANTI-HUMAN COMPLEMENT C4
FDA 510(k)
FDA Class 2
·Immunology
MeDiCa
FDA UDI
SCIMEDX CORPORATION·00813545027292·Multi-Ab III Rat (Kidney + Stomach) 96 Test Kit
MeDiCa
FDA UDI
SCIMEDX CORPORATION·00813545027308·Multi-Ab III Rat (Kidney + Stomach) 4 & 8 well ...
MeDiCa
FDA UDI
SCIMEDX CORPORATION·00813545027278·Multi-Ab III (AMA, ASMA) Rat (Kidney + Stomach)...
MeDiCa
FDA UDI
SCIMEDX CORPORATION·00813545027322·Multi-Ab III Mouse (Kidney + Stomach) 96 Test Kit
STATIC VESSEL ANALYZER
FDA 510(k)
FDA Class 2
·Ophthalmic
LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MeDiCa
FDA UDI
SCIMEDX CORPORATION·00813545027353·Multi-Ab III Mouse (Kidney + Stomach) 96 Test Kit
HEARTMATE II LVAS
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·April 24, 2014
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 23, 2012
PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·August 17, 2010
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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