20 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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MULTIPLE LABELS, POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE
FDA 510(k)
FDA Class 1
·General Hospital
Woven Filiform Coude Tip
FDA UDI
C. R. Bard, Inc.·00801741073243·Woven Filiform Coude Tip
Cook
FDA UDI
COOK INCORPORATED·00827002148741·Universal Ureteral Catheter
2040 Ceramic Brackets
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746005633·COSMETIC 20/40 UR CUSP 018 T=0 A+8 R=0
ES™ TROCHANTERIC NAIL, LEFT, Ø11mm x 30cm x 125°
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665014334·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694033046·2.3mm x 5mm Safety Screw
BIB
FDA Adverse Event
Other
·NUMED, INC.·Product code LIT·July 27, 2001
MICROLIFE WRIST WATCH BLOOD PRESSURE, MODEL BP-3BU1-5, WITH OPTIONAL THERMAL PRINTER
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981157135·Cambria Trial without Depth Stop
PYRENEES® Cervical Plate System
FDA UDI
VB Spine LLC·10888857241947·FAST Drill Guide, Translational
TVT EXACT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·May 3, 2022
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 27, 2013
ENDOPATH* TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GEA·March 17, 2011
SAF-T -INTIMA SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code FOZ·March 24, 2008
HEARTMATE 3 LVAS IMPLANT KIT
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·July 30, 2020
Portex Hypodermic Needle-Pro 5 ml Syringe, 20g x 1'' Needle Catalog Number: 4251
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code FMJ·September 9, 2004
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014