24 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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CURASAN OSSEOLIVE DENTAL
FDA 510(k)
FDA Class 2
·Dental
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK111151·DD tempMED are pre-colored dental milling blank...
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481118258·LOCATOR R-Tx Abutment For 3.8mm Premium, Sweden...
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08806390809641·
MESA® Spinal System
FDA UDI
VB Spine LLC·10888857231108·MESA 2 Deformity 360° Screw Size Ø11.5x105 mm
Life Instruments
FDA UDI
Life Instrument Corporation·M930811110500·Cobb Curette #5 Str
Life Instruments
FDA UDI
Life Instrument Corporation·M930811110510·Cobb Curette #5 Ang
REMEL SABOURAUD DEXTROSE CONTACT PLATE
FDA Adverse Event
Malfunction
·REMEL THERMO FISHER SCIENTIFIC·Product code JSG·August 7, 2017
K2M General Instruments
FDA UDI
VB Spine LLC·10888857531130·Trial Size 12x14x9 mm, 6°
Summa Orthopaedics System Surgical Instrument
FDA UDI
Jeil Medical Corporation·08806390862684·
Pharmaceutical Innovations
FDA UDI
PHARMACEUTICAL INNOVATIONS INC·00300361111057·Other-Sonic High Viscosity Generic Ultrasound G...
POWDER-FREE, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEPF1
FDA 510(k)
FDA Class 1
·General Hospital
SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LINER: VERSAFITCUP DM 01.26.2854MHC DOUBLE MOBILITY HC LINER Ø 54/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·February 13, 2024
BD INSULIN PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 9, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·September 23, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 2, 2011
The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·June 12, 2013
Medtronic Neurosurgery C/n 3805-015 Peelaway Introducer Sheath, Disposable 15 F
FDA Recall
Terminated
·Medtronic Neurosurgery·Product code GWG·July 5, 2005