18 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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CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K1230000·Rod Holder, Curved, 5.5 mm
INTEGRA TOTAL FOOT SYSTEMS
FDA 510(k)
FDA Class 2
·Orthopedic
LEONE SPA
FDA UDI
LEONE SPA·08033707002888·COIL SPRINGS MEMORIA W/WOUND ENDS CLOSED
EXPERT - Flexible Joint Fixation System
FDA UDI
GM DOS REIS INDUSTRIA E COMERCIO LTDA·07899258663784·EXPERT ACL – Flexible ACL Knotless Fixator with...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702271362·ELVAREX 3/THIGH HIGH/PROFILE, SLANT, OPEN TOE, ...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702557244·ELVAREX 3/KNEE HIGH/PROFILE-SLANT-OPEN TOE-ELEP...
Electro Lavage
FDA UDI
MECTRA LABS, INC.·00817984010518·Electro Lavage J Hook Double Bottle
Liberty SI
FDA UDI
Spinal Simplicity, LLC·M9431001230000·Lateral SI Joint Fusion Implant 10mm Size D
Monkey Rings™ External Fixation System
FDA UDI
Paragon 28, Inc.·00889795129116·Universal Joint
SMART READ BIOLOGICAL TEST PACK
FDA 510(k)
FDA Class 2
·General Hospital
HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-329M SERIES
FDA 510(k)
FDA Class 2
·Physical Medicine
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·July 7, 2025
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 21, 2013
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code FRN·September 26, 2014
ATTAIN ABILITY
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·June 14, 2011
PUMP 1886 780G OUS BLE PUMP MG/DL
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·September 6, 2023
Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use in todays growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 14, 2013
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020