19 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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REPROCSSED LINVATEC SHAVERS
FDA 510(k)
FDA Class 2
·Orthopedic
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·H65810126131·Maxima Gutta Percha CC 20/Vl
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040099964·Maxima Gutta Percha CC 20/Vl
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040140861·Maxima Gutta Percha CC 20/Vl
CMC
FDA UDI
FGX INTERNATIONAL INC.·00193033428320·
CMC
FDA UDI
FGX INTERNATIONAL INC.·00193033428337·
CMC
FDA UDI
FGX INTERNATIONAL INC.·00193033428313·
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0106130·Trial, 26 x 13mm, 8 Degree, Tapered, Straight
Battalion
FDA UDI
ALPHATEC SPINE, INC.·00840967187228·Battalion, LLIF Trial, 10°, 26 mm Wide, 13 mm X...
MAGELLAN-2200, MODEL 1
FDA 510(k)
FDA Class 2
·Anesthesiology
MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Octane M
FDA UDI
Choice Spine, LP·10885862236388·
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 21, 2013
ACS POLY W/10 LIP 32 GR2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDL·February 24, 2011
LINOX SD 65/16
FDA Adverse Event
Injury
·BIOTRONIK GMH AND CO·Product code LWS·March 10, 2008
Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·October 2, 2019
Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·October 18, 2017
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
FDA Enforcement
Class II
·Ongoing·Stimwave Technologies Inc·September 9, 2020