21 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PROANGLE DISPOSABLE PROPHY ANGLE
FDA 510(k)
FDA Class 1
·Dental
Humelock II Cemented Reversible Shoulder
FDA UDI
FX SOLUTIONS·03701037308394·MOBILITY TRIAL CUP Ø36 + 3
Humelock II Cemented Reversible Shoulder
FDA UDI
FX SOLUTIONS·03701037302811·HUMERAL CUP MOBILITY PE/TA6V Ø36/+3
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481112591·LOCATOR R-Tx Abutment for 4.1mm External Hex Co...
SilverSpeed
FDA UDI
Micro Therapeutics, Inc.·00836462003118·16 Hydrophilic Guidewire
SilverSpeedTM
FDA UDI
Micro Therapeutics, Inc.·00847536004672·103-0603-200 SILVERSPEED 16
SilverSpeedTM
FDA UDI
Micro Therapeutics, Inc.·00847536004696·103-0603-200 SIVERSPEED 16 GWIRE ATH
SilverSpeedTM
FDA UDI
Micro Therapeutics, Inc.·00847536004689·103-0603-200 SIVERSPEED 16 GWIRE ATH
BD SYRINGE 10ML LL S/C 200
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 25, 2025
BD SYRINGE 10ML LL S/C 200
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 25, 2025
SPIFE CHOLESTEROL PROFILE KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HE
FDA 510(k)
FDA Class 2
·Dental
BOOMERANG PEEK FUSION DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MQP·January 14, 2011
BD SYRINGE 5ML LL SP125
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 1, 2025
CORTSCR Ø3.5 L30 TI
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code KWQ·April 2, 2013
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·March 22, 2011
ANALYTICAL P MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·April 16, 2008
BD PRECISIONGLIDE¿ HYPODERMIC NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMI·November 27, 2018
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018