15 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Air compression therapy system FO-3001; Air compression therapy system FO-3008
FDA 510(k)
FDA Class 2
·Physical Medicine
Disposable Blade
FDA UDI
KATENA PRODUCTS, INC.·00841668113196·BARD-PARKER BLADE #11 PACK OF 50
Disposable Blade
FDA UDI
KATENA PRODUCTS, INC.·00841668113202·BARD-PARKER BLADE #15 PACK OF 50
36M - Black & Veach - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588011820·36M - Black & Veach - Metal
TRI-LOCK HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180
FDA 510(k)
FDA Class 2
·Cardiovascular
UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM
FDA Adverse Event
Injury
·BECKMAN COULTER, INC.·Product code JGS·August 5, 2011
BONE WAX
FDA Adverse Event
ETHICON, INC.·Product code MTJ·September 30, 2014
12.6CM TAPERED ATTACHMENT, BLACK MAX
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HSZ·July 2, 2013
ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM
FDA Adverse Event
Death
·SILK ROAD MEDICAL·Product code NTE·August 21, 2025
ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM
FDA Adverse Event
Injury
·SILK ROAD MEDICAL·Product code NTE·August 21, 2025
3500 CP-G AIR/OXYGEN MIXER
FDA Adverse Event
Malfunction
·SECHRIST INDUSTRIES INC.·Product code DTZ·July 10, 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
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025