10,000 results
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48ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·March 3, 2015
RESTORATION ADM X3 INS 28/48
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·June 13, 2016
SYNCHRO .014GUIDE WIRE 35 CM TIP
FDA Adverse Event
Injury
·STRYKER NEUROVASCULAR-UTAH·Product code DQX·September 18, 2017
TARGET 360 NANO 2 MM X 3 CM
FDA Adverse Event
Injury
·STRYKER NEUROVASCULAR CORK·Product code HCG·September 18, 2017
TARGET HELICAL NANO 1MM X 1CM
FDA Adverse Event
Injury
·STRYKER NEUROVASCULAR CORK·Product code HCG·September 18, 2017
SYNCHRO 2/14 200 CM STANDARD
FDA Adverse Event
Injury
·STRYKER NEUROVASCULAR-UTAH·Product code DQX·September 18, 2017
EMBLEM MRI S-ICD
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code LWS·February 4, 2022
UNKN REFLECTION METAL CUP
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDG·March 14, 2022
UNKN R3 SHELL
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDG·March 14, 2022
TABOTAMP SNOW ABS
FDA Adverse Event
Injury
·ETHICON INC.·Product code LMG·October 30, 2019
TABOTAMP SNOW ABS
FDA Adverse Event
Injury
·ETHICON INC.·Product code LMG·October 30, 2019
TABOTAMP SNOW ABS
FDA Adverse Event
Injury
·ETHICON INC.·Product code LMG·October 30, 2019
TABOTAMP SNOW ABS
FDA Adverse Event
Injury
·ETHICON INC.·Product code LMG·October 30, 2019
TABOTAMP SNOW ABS
FDA Adverse Event
Injury
·ETHICON INC.·Product code LMG·October 30, 2019
TABOTAMP SNOW ABS
FDA Adverse Event
Injury
·ETHICON INC.·Product code LMG·October 30, 2019
3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC 150 mm there is no indication for Synthes Cannulated Drill Bits which is used with the Synthes Cannulated Screw. The Synthes Cannulated Screw, used with the threaded washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist, and forefoot.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·June 10, 2015
RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215, 31-323220, 31-323230, 31-323240 - Product Usage: Bit, Drill.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·December 23, 2020
3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)00812926029696 - Product Usage: A drill bit facilitates implant insertion
FDA Recall
Terminated
·Trilliant Surgical, LLC·Product code HTW·October 10, 2019
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
FDA Pre-Market Approval
FDA Class 2
·ABBOTT AXSYM AFP
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
FDA Pre-Market Approval
FDA Class 2
·TANDEM(R)-E AFP