19 results
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24ms
·
Sources: EU EUDAMED, US FDA
NOVASHIELD INJECTABLE NASAL PACKING AND STENT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221037855·Unitek(TM) Bicuspid Band General Purpose Wide U...
Cadet Cervical Cage
FDA UDI
VALORUS SPINE LLC·00811771034268·Cadet Cervical Cage, 14mm x 17mm x 04mm, 7° Lor...
K2M General Instruments
FDA UDI
VB Spine LLC·10888857583108·Modular Trial 22x8x9mm, 7°
Cadet Cervical Cage
FDA UDI
VALORUS SPINE LLC·00811771033636·Cadet Cervical Cage, 14mm x 17mm x 04mm, Non-Lo...
NEWGEL AND NEWGEL PLUS E
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ZIMMER DTO PIN PRESS INSTRUMENT
FDA 510(k)
FDA Class 2
·Orthopedic
UniTip Catheter
FDA UDI
Unisensor AG·07640172971406·
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 4, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code GEI·June 27, 2011
AUGMENTED INSERT
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 29, 2011
HIP HEAD, 10/12 TAPER, 28MM, +5MM
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWY·June 29, 2011
POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025
POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025
POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025
POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025
Allegiance Laminated Wood Crutches, item 74151-010, Large Adult - 51'' - 64''; 1 pair individually shrink wrapped, 10 pairs per case; Distributed by Cardinal Health, McGaw Park, IL 60085-6787 USA, Made in China
FDA Recall
Terminated
·Duro-Med Industries, Inc.·Product code IPR·August 4, 2004
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