15 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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Hair Growth Device
FDA 510(k)
FDA Class 2
·Physical Medicine
VERSALOOP™ Anchor 2 Suture, 2.5mm
FDA UDI
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION·10818674024799·
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319744567·Adson Dura Hook 8" (20cm), blunt 5mm hook at a ...
Adler Instrument Company
FDA UDI
Adler, Inc.·00810123201495·KNIFE HDL NO 7
Dilator, Vascular, acc. Garrett 35cm 4.5mm
FDA UDI
Geister Medizintechnik GmbH·04057034047583·Dilator, Vascular, acc. Garrett
35cm 4...
DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
EQUINOXE 145-DEG PE 46MM HUM LINER +0
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·September 23, 2024
HOT MAXX BIOPSY FORCEPS WITHOUT SPIKE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL, INC.·Product code KGE·August 4, 2011
PLUS SL
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPEDICS AG·Product code KWY·October 23, 2008
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 8, 2013
Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·August 28, 2013
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 19, 2023
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 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