20 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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XO Cross Support Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Trinity Acetabular Hip System
FDA UDI
CORIN LTD·05055343898550·Modular Head Trial Ø22mm/-2.0/S (12/14)
CoRoent
FDA UDI
Nuvasive, Inc.·00887517628923·CoRoent Ant TLIF Ti, 11x10x32mm 12°
Bendini
FDA UDI
Nuvasive, Inc.·00887517728203·Bendini Template, Rod Hinged
Kompressor™ Compression Screw System
FDA UDI
Ascension Orthopedics, Inc.·10381780065753·The mini Kompressor Compression Screw is a two-...
PMT CORPORATION - STEREOTACTIC
FDA UDI
PMT CORPORATION·00650551068259·BRAINLAB sEEG KIT: 2103-34 (QTY 2), 2103-52, 21...
OLECRA INTRAMEDULLARY FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
FDA 510(k)
FDA Class 2
·Orthopedic
BRONCHO CATH
FDA Adverse Event
Malfunction
·COVIDIEN·Product code BTS·October 29, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·August 9, 2011
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013
STABLE BASE
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code DRX·November 4, 2021
ENDO-MODEL MODULAR KNEE SYSTEM
FDA Adverse Event
Malfunction
·WALDEMAR LINK GMBH & CO. KG·Product code KRO·May 24, 2022
ENDO-MODEL MODULAR KNEE SYSTEM
FDA Adverse Event
Malfunction
·WALDEMAR LINK GMBH & CO. KG·Product code KRO·May 24, 2022
ENDO-MODEL MODULAR KNEE SYSTEM
FDA Adverse Event
Malfunction
·WALDEMAR LINK GMBH & CO. KG·Product code KRO·May 24, 2022
Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M00326010 REF 2601, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
FDA Enforcement
Class II
·Terminated·Stryker Neurovascular·November 6, 2019
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014
BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015