13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Alere Afinion HbA1c and ACR on Afinion 2 analyzer
FDA 510(k)
FDA Class 2
·Hematology
TROCHANTERIC NAIL KIT, TI GAMMA3 10X170MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 14, 2012
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100769·FLIERINGA FIXATION RING 15MM
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306804007·Castroviejo Suturing Forceps, Tying Platform, T...
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100776·FLIERINGA FIXATION RING 16MM
RHEAD
FDA UDI
Stryker GmbH·00886385023854·Stem Trial; Extended Collar; Size 2
Sklar®
FDA UDI
SKLAR CORPORATION·10649111195693·HALSTED MOSQ FCP STR 1X2 5"
C350 POWERED WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS...
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·July 21, 2011
SCRDRIVERSHAFT-1.5/2 CRUCIF SELF-HOLD L9
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXX·June 15, 2013
PINN CAN BONE SCREW 6.5MMX40MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·October 14, 2014
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·October 27, 2021