19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Nam illumination probe with chopper
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NuVasive
FDA UDI
Nuvasive, Inc.·00195377046635·NTS Standard Tube, 26x70mm
VITROS
FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750008513·VITROS Chemistry Products AMYL Slides
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112564·BARRON CORNEAL PUNCH 6.0MM
36M - MSHA Miners
FDA UDI
Certified Safety Manufacturing, Inc.·00766588026206·36M - MSHA Miners
EZ-TRAVELER 3000 SERIES MANUAL WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
CARRAKLENZ AND ULTRAKLENZ
FDA 510(k)
FDA Unclassified
·Unknown
TARGETING ARM PROX. LAT TIBIA LEFT
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS SELZACH·Product code LXH·February 2, 2012
UNKNOWN EMPRINT ANTENNA
FDA Adverse Event
Injury
·COVIDIEN MEDICAL PRODUCTS·Product code NEY·May 29, 2026
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 3, 2026
VITROS IMMUNODIAGNOSTICS PRODUCTS, ANTI-HAV IGM REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code LOL·August 11, 2011
PROTEGE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 22, 2014
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 2, 2013
VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670 and packaged as 90 slides/pack catalog number 8112724 VITROS AMYL Slides quantitatively measure amylase (AMYL) activity in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·November 27, 2013
VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·June 24, 2020
VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670 and packaged as 90 slides/pack catalog number 8112724 VITROS AMYL Slides quantitatively measure amylase (AMYL) activity in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code CIW·June 12, 2013
VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code CIW·May 11, 2020
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
HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070 HAA60-14050 HAA60-14080 HAA60-14090 HAA60-15020 HAA60-15030 HAA60-15040 HAA60-15050 HAA60-15060 HAA60-16030 HAA60-16040 HAA60-16050 HAA60-16070 HAA60-16090 HAA60-17040 HAA60-17060 HAA60-17080 HAA60-18010 HAA60-18030 HAA60-18040 HAA60-18050 HAA60-18060 HAA60-18090 HAA60-20030 HAA60-20040 HAA60-20050 HAA60-20060 HAA60-20080 HAA60-20090 HAA60-22050 HAA60-22060 HAA60-25030 HAA60-25040 HAA60-25050 HAA60-25060 HAA60-30060 HAB60-09030 HAB60-10030 HAB60-10040 HAB60-11040 HAB60-11050 HAB60-12040 HAB60-12060 HAB60-13040 HAB60-13050 HAB60-13060 HAB60-14050 HAB60-15060 HAB60-16070 HAB60-16090 HAB60-17080 HAB60-18010 HAB60-18090 HAB60-20080 HAB60-20090 808200000 Product Usage: These devices are intended for osteosynthesis, external fixation of fractures or bone lengthening procedures.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019