12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CITRESPLINE and CITRELOCK ACL Implants
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777495·LUMBAMED PLUS FLEX PAD M SILVER II
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777488·LUMBAMED PLUS FLEX PAD M SILVER I
Accent Buccal Tube
FDA UDI
ORMCO CORPORATION·00889989054361·ORTHOS ACCENT 15DBL UFM -10X22X21 LT
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319744772·Fomon Nasal Chisel 6-3/4" (16.9cm), single guar...
LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
COCAINE DIPSTICK TEST, MODEL D747-A
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LRG TITANIUM LIGATING CLIP
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·October 21, 2008
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 11, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·July 8, 2013
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
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