22 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CUBEScan BioCon-1100
FDA 510(k)
FDA Class 2
·Radiology
MAYO-LEXER SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896055377·MAYO-LEXER SCISSORS CURVED ROUND TUNGSTEN CARBI...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694007009·Reconstruction Plate Bending Plier, No Ratchet
ELMED
FDA UDI
ELMED INCORPORATED·00842180102804·MONOPOLAR RF-CABLE WITH MALE BANANA 1/16" RECES...
VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QJR·May 22, 2020
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·October 24, 2014
TOTAL ASR ACET IMP SIZE 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·July 1, 2013
HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GEI·December 13, 2019
SCREW, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWC·March 24, 2015
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·March 24, 2015
PROXIMATE*HCS HEMORR CIR STAPL
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 31, 2019
HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·November 3, 2019
PROXIMATE*PPH PROCEDURE SET
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 3, 2019
ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 17, 2019
BD ULTRA FINE¿ SHORT INSULIN PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·April 5, 2018
SYNVISC (HYLAN G-F 20) INJECTION
FDA Adverse Event
Other
·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·April 25, 2013
Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016