9 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STONE DISLODGER, BASKET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
artegral
FDA UDI
Merz Dental GmbH·D7091970121·anteriors; shade A4; mould BM
Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MANUEL BILIRUBIN REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·February 20, 2013
AMISTEM H FEMORAL STEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 14, 2011
AVON PAT/FEM JOINT SML
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code KRR·July 31, 2014
BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·January 30, 2019
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021