24 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
FDA 510(k)
FDA Class 2
·Orthopedic
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515061927·O.R. Sci, S/B, str, 5 3/4"
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR21030401·Compound retraction arch max. .016"x.022" / 30°
BONE REDUCTION CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896050969·BONE REDUCTION CLAMP WITH LONG RATCHET
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR21030400101·Compound retraction arch max. .016"x.022" / 30°
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR21030400051·Compound retraction arch max. .016"x.022" / 30°
VIDAS HCG 60 TESTS - 30405
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code JHI·March 25, 2021
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0130400·ROD REDUCER, AXIAL
LIGHT SABER INTRODUCER NEEDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VIDAS HCG 60 TESTS
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code DHA·December 22, 2020
TGS UKA SYSTEM
FDA Adverse Event
Injury
·CAYENNE MEDICAL INC.·Product code HSX·May 15, 2014
BIOMET CC CRUCIATE TRAY 67MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·December 14, 2016
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·May 9, 2013
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·September 19, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 25, 2011
BD PLASTIPAK¿ 3-PIECE SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·July 27, 2022
Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·February 19, 2014
HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
FDA Enforcement
Class II
·Terminated·Terumo BCT, Inc.·November 22, 2017
HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO
FDA Enforcement
Class II
·Terminated·Terumo BCT, Inc.·November 22, 2017