14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ISOLA(R) TRANSVERSE ROD DUAL CONNECTOR
FDA 510(k)
FDA Class 2
·Orthopedic
Bosworth Trim II
FDA UDI
Harry J Bosworth Company·H66809210901·PEMA Temp C&B Standard Kit, 6-1.5 oz Pwd, 4 oz ...
PAQ.210x295x140/QT-HS80/CARDISMART/MAC 5
FDA UDI
AB MEDICA GROUP, S.A.·08428763090533·
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668112359·SURG-I-BAND PURPLE GLOW
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111000·INSTRUMENT CADDY SMALL
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869657365·MOSS XT Ti Pedicle Screw Ø10.0x90mm grey, cannu...
Metal Cannulated Screw
FDA 510(k)
FDA Class 2
·Orthopedic
OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 40 MM
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code MNI·November 11, 2010
X-STOP PEEK INTERSPINOUS SPACER
FDA Adverse Event
Injury
·MDT KYPHON SUNNYVALE MFG·Product code NQO·January 17, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 9, 2014
RT-5100 Refractor, a component of the Epic-5100 System.
FDA Enforcement
Class III
·Terminated·Nidek Inc.·December 26, 2018
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024