21 results
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22ms
·
Sources: EU EUDAMED, US FDA
PENLON JUMBO CARBON DIOXIDE ABSORBER
FDA 510(k)
FDA Class 1
·Anesthesiology
TLX
FDA UDI
Nuvasive, Inc.·00887517729538·TLX Implant, 10x11x26mm 15°
Oph.Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668117668·Castroviejo Forceps, .3mm, Wide Handle
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00840967189123·Angled Connector, Right, 30°
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00840967189147·Angled Connector, Right, 40°
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00840967189154·Angled Connector, Right, 45°
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00840967189116·Angled Connector, Right, 25°
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00840967189161·Angled Connector, Right, 50°
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00840967189130·Angled Connector, Right, 35°
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197494328·Micro Scissors
curved...
SCRAMBLER ST 5 TENS DEVICE
FDA 510(k)
FDA Class 2
·Neurology
CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SEXTANT SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code MCV·October 29, 2009
DEPUY ASR XL FEM IMP SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·May 8, 2014
KNIGHTSTAR 330
FDA Adverse Event
Malfunction
·GALWAY (RC) - RX·Product code MNT·October 17, 2012
ASR ACETABULAR IMPLANT 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 11, 2010
SUREFORM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code GDW·November 15, 2023
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
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
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024