16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACCULIF TL AND PL CAGE
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550162·GENUMEDI PT KNEE SUP SILVER L EW VII
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550223·GENUMEDI PT KNEE SUP SILVER R EW VII
HIGH-WAVE
FDA UDI
Denplus Inc·D8451141217·HIGH-WAVE, VIR, 2.3 kg
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00887868247828·
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00887868558559·
BIOMET KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304231849·
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221037046·Unitek(TM) Bicuspid Band General Purpose Narrow...
MODIFICATION TO BONE GRAFT WASHER
FDA 510(k)
FDA Class 2
·Orthopedic
MAC-MOBILE AQUATIC CHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·May 28, 2015
COOK CELECT PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·December 14, 2020
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·October 3, 2014
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·June 3, 2013
RESTORE ULTRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·June 22, 2011
PKG, 5MM INSERT, PARK FORCEPS, P/N 0250080733 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014