68 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FIX-C PEEK Anterior Cervical Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
Packed iTero Mobile Computing Unit RMA 5D Plus
FDA UDI
Align Technology, Inc.·00816063021063·PPC RMAs
NA
FDA UDI
SYNTHES (U.S.A.) LP·10886982152503·5.0MM LCKNG SCREW SLF-DRLG W/T25 STARDRIVE RECE...
Fibula Plate 3.5mm
FDA UDI
I.T.S. GmbH·09120047298299·Fibula Plate 3.5mm, 6-Hole, Left
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
FDA 510(k)
FDA Class 1
·General Hospital
SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2
FDA 510(k)
FDA Class 2
·General Hospital
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·October 29, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 15, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2013
I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibula Plate 3.5mm; Article Numbers: 21225-4, 21225-6, 21225-8, 21225-10, 21225-12, 21226-4, 21226-6, 21226-8, 21226-10, 21226-12. 3. Universal Tubular Plate; Article Numbers: 21601-5, 21601-6, 21601-7, 21601-8, 21601-10, 21601-12, 21601-14, 21601-16.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026
LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter (eIFU) REF# e2400-51
FDA Recall
Terminated
·LeMaitre Vascular, Inc.·Product code DQO·February 7, 2017
LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50
FDA Recall
Terminated
·LeMaitre Vascular, Inc.·Product code DQO·February 7, 2017
LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-53
FDA Recall
Terminated
·LeMaitre Vascular, Inc.·Product code DQO·February 7, 2017
LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU) REF# 2401-52
FDA Recall
Terminated
·LeMaitre Vascular, Inc.·Product code DQO·February 7, 2017
LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52
FDA Recall
Terminated
·LeMaitre Vascular, Inc.·Product code DQO·February 7, 2017
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e2401-50
FDA Recall
Terminated
·LeMaitre Vascular, Inc.·Product code DQO·February 7, 2017
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU) REF# 2401-50
FDA Recall
Terminated
·LeMaitre Vascular, Inc.·Product code DQO·February 7, 2017
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with Introducer (paper IFU) REF# 2401-53
FDA Recall
Terminated
·LeMaitre Vascular, Inc.·Product code DQO·February 7, 2017
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-51
FDA Recall
Terminated
·LeMaitre Vascular, Inc.·Product code DQO·February 7, 2017
LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) REF # e2400-53
FDA Recall
Terminated
·LeMaitre Vascular, Inc.·Product code DQO·February 7, 2017