17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743632·LEVAMED ANKLE SUPPORT SAND VI
DENTO-PREP PARTICLE MICROBLASTER
FDA 510(k)
FDA Class 2
·Dental
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964152290·Endo Carry-on Procedure Kit contains Basin, Enz...
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890108160·Zirlux Multi-Unit Prosthetic Screw - Unigrip Dr...
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR50108161·Band removing plier
S-LIFT®
FDA UDI
SPINEFRONTIER, INC.·00190361038320·TRIAL STRAIGHT, 16MM X 19MM
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033197806·
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100160·Compressor, Canoe
MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER
FDA 510(k)
FDA Class 2
·Anesthesiology
SHARP BRAND ACUPUNCTURE NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
AMITRODE TRIPOLE 16
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 14, 2013
8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code MGB·March 2, 2011
RIATA ST OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008
Vertical Brake Hubs component of the Philips MX8000 Series Dual v. Exp. Computed Tomography System, Serial Numbers: 8008-8413, 80001-800022, Model #728130, 510 (k) #K010817. Product Usag: The MX 8000 series Dual v. Exp are Computed Tomography X-Ray system units intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·June 3, 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
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 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