20 results · 29ms · Sources: EU EUDAMED, 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