12 results · 21ms · Sources: EU EUDAMED, 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