15 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FLEXLENS(METHAFILCON A)
FDA 510(k)
FDA Class 2
·Ophthalmic
CONNECTOR 22F - 15M
FDA UDI
Intersurgical Incorporated·05030267057344·CONNECTOR 22F - 15M
TROCHANTERIC NAIL TRAY, LONG, Ø10mm x 125°
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665038989·
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190660·Femoral Sizing Guide Bushing Neut/+2mm
Eye Shield
FDA UDI
KATENA PRODUCTS, INC.·00841668111123·FOX EYE SHIELD ALUMINUM
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0620000·Universal Removal Set
KEYMED FLEXIBLE ESOPHAGEAL DILATORS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCH
FDA 510(k)
FDA Unclassified
·Unknown
5CM, 33CM PEEK MONOPOLAR HANDLE 33CM
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code KOG·January 22, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 28, 2014
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 17, 2011
36MM COCR MOD HD +3MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·January 19, 2018
ARCOMXL 36MM RLC LNR HW SZ25
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·January 19, 2018
ARCOS CON SZ A HI 50MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·January 19, 2018
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024