19 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Oren LED Perioral Light Therapy System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RIGIDFIX
FDA UDI
Medos International Sàrl·10886705020089·RIGIDFIX CURVE Femoral Rod Soft Tissue Only 7mm...
NA
FDA UDI
Synthes GmbH·10886982153098·3.5MM LOCKING SCREW SELF-TAPPING 24MM
Bookler Table Mounted Retractor Systems
FDA UDI
FLEXBAR MACHINE CORPORATION·00842102107405·Bookler Bariatric Accessory Set w/24" Post
GLOBAL AP
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295090946·GLOBAL AP GENERAL CASE & INSERTS
GLOBAL AP
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295090915·GLOBAL AP HUMERAL 2 CASE LID
GLOBAL AP
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295090854·GLOBAL AP HUMERAL 1 CASE LID
GLOBAL AP CTA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295090991·GLOBAL AP CTA CTA CASE ASSEMBLY
GLOBAL AP
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295090892·GLOBAL AP HUMERAL 2 CASE & INSERT
GLOBAL AP
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295090830·GLOBAL AP HUMERAL 1 CASE & INSERTS
GLOBAL AP
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295090960·GLOBAL AP GENERAL CASE LID
GLOBAL AP CTA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295091011·GLOBAL AP CTA CTA LID
TORQUE DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
SELECTIVA GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code ITI·October 30, 2014
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·August 9, 2011
FINELINE II
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·July 9, 2013
UNSPECIFIED BD SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·July 1, 2019
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 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.·May 3, 2017