9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Alm Retractor
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896048416·Alm Retractor Self Retaining
C.T.M. MOBILITY SCOOTER, MODEL HS-890
FDA 510(k)
FDA Class 2
·Physical Medicine
ORTHOALIGN PLUS SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
IAB : 8 FR - 40 CC
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·November 7, 2008
POLYFLUX H CAPILLARY DIALYZER
FDA Adverse Event
Injury
·GAMBRO DIAYLSATOREN GMBH·Product code KDI·August 3, 2011
ROD Ø5.5 SOFT CURV L65 TI
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·July 16, 2013
BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.
FDA Enforcement
Class II
·Terminated·Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables·December 28, 2016
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025