20 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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COLLAGEN NERVE CUFF
FDA 510(k)
FDA Class 2
·Neurology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743618·LEVAMED ANKLE SUPPORT SAND IV
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0120140·Screwdriver, Polyaxial, Standard, Cannulated, L...
EYE SENTIAL
FDA UDI
FGX INTERNATIONAL INC.·00193033444641·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450308134·
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482046074·Symmetry® Knife Handle, #4L, Long, 8 3/8 in, 21...
DISPOSBABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
True Position®
FDA UDI
ATLAS SPINE, INC.·M68112080128140·28mm x 14mm Lordotic Spacer
Octane Straight PC
FDA UDI
Choice Spine, LP·10885862278005·
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962107096·KNIFE HANDLE, 8 3/8", #4L
Octane Straight
FDA UDI
Choice Spine, LP·10885862235909·
BD VACUTAINER® SST¿ II ADVANCE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·March 28, 2025
2520274-2013-01608
FDA Adverse Event
Malfunction
·SYNTHES (USA) WEST CHESTER, PA·Product code MCV·March 20, 2013
ADVANTAGE SERIES 29
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·March 3, 2011
LIGASURE LAPAROSCOPIC SLR/DIV
FDA Adverse Event
Malfunction
·COVIDIEN LP (US SURGICAL)·Product code GEI·March 12, 2008
Pinnacle Destination Guiding Sheath, 6 French, 45 cm, Hockey Stick Tip, Tuohy-Borst Valve, Lot ME07, 510 (K) K012854 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.
FDA Recall
Terminated
·Terumo Medical Corporation·Product code DYB·June 24, 2010
Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot MD24, MD31, ME07, & ME14. 510(k) K012812 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.
FDA Recall
Terminated
·Terumo Medical Corporation·Product code DYB·June 24, 2010
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 Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022