18 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LIFELINES TRACKIT
FDA 510(k)
FDA Class 2
·Neurology
NA
FDA UDI
Nuvasive, Inc.·00887517163219·NVM5 EMG ET Tube, 6mm ENT Kit
VIvid NuFil Syringe A-3
FDA UDI
PEARSON DENTAL SUPPLIES, INC.·D724D0104600·
AOS MODULAR NAIL 10.0mm x 46cm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665003079·
OSS MOD EXPANDABLE SZ20 SEG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·June 14, 2019
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0104000·Caddie, Tulip Connectors
PUMA-G System™
FDA UDI
Coaptech, Inc.·00850026037227·Percutaneous Ultrasound Gastrostomy (PUG) Syste...
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0100600·Caddie, Modular Bone Screws
URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A
FDA 510(k)
FDA Class 2
·Clinical Toxicology
VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192
FDA 510(k)
FDA Class 1
·Microbiology
MBT CEM KEEL TIB TRAY SZ4
FDA Adverse Event
Injury
·9616671 DEPUY (IRELAND)·Product code NJL·March 19, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 8, 2011
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 11, 2007
ENDOPATH ETS FLEX
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·September 9, 1997
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
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
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, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018