22 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Swedge Pedicle Screw Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
ADSON CEREBELLAR RETRACTOR
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896026698·ADSON CEREBELLAR RETRACTOR STRAIGHT ARMS BLUNT ...
MUST LT 25MM LONG - PEDICLE SCREW Ø6X45 CANN
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·January 19, 2024
WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553
FDA 510(k)
FDA Class 1
·Clinical Chemistry
COMBAT READY CLAMP
FDA 510(k)
FDA Class 2
·Cardiovascular
MUST LT 03.57.035 MUST LT 15MM SHORT - PEDICLE SCREW Ø7X45 CANN
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·November 18, 2022
M.U.S.T. PEDICLE SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·September 18, 2025
PEDICLE SCREW MUST LT 15MM SHORT - PEDICLE SCREW Ø4.5X30 CANN
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·November 8, 2023
M.U.S.T. PEDICLE SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWQ·July 16, 2025
MUST LT 03.59.234 MUST LT 25MM LONG - PEDICLE SCREW Ø7X40 CANN
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·February 16, 2022
MUST LT 15MM SHORT - PEDICLE SCREW Ø8X40 CANN
FDA Adverse Event
Death
·MEDACTA INTERNATIONAL SA·Product code NKB·March 29, 2023
MEDLINE UNITE
FDA Adverse Event
Injury
·MEDLINE INDUSTRIES, LP·Product code JDR·December 23, 2025
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FRN·October 22, 2014
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 16, 2013
MUST LT MUST LT 25MM LONG - PEDICLE SCREW 6X45 CANN
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·July 7, 2021
MUST LT MUST LT 15MM SHORT - PEDICLE SCREW Ø6X40 CANN
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·November 3, 2021
MECTALIF OBLIQUE (TI PEEK) TIPEEK 10X24X10 L5°
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MAX·June 25, 2024
STYLE 68 SALINE FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·September 13, 2017
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014