17 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Symmetry Littauer
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482047590·Symmetry® Scissors, Littauer Stitch, 5 1/2 in
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197056298·Heaney Hysterctomy Clamp
1 toot...
icotec Cervical Cage, Anatomic Probe, 6 mm x 13 mm
FDA UDI
icotec AG·07640140433820·icotec Cervical Cage, Anatomic Probe, 6 mm x 13 mm
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197056281·Heaney Hysterctomy Clamp
1 toot...
REMINGTON I-LIGHT HAIR REMOVAL SYSTEM
FDA Adverse Event
Injury
·SHASER INC·Product code ONF·May 21, 2021
BIOMED WOUND CLEANSER
FDA 510(k)
FDA Unclassified
·Unknown
EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS
FDA 510(k)
FDA Class 2
·Orthopedic
60" LOADING CAR ASSEMBLY
FDA Adverse Event
STERIS MEXICO, S. DE R.L. DE C.V.·Product code FLE·October 3, 2014
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 31, 2013
HEARTSTART MRX - EMS DEFBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEATLHCARE·Product code MKJ·June 16, 2011
BD MAX¿ CPO
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·May 13, 2025
BD MAX¿ CPO
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·January 21, 2025
VENFLON PRO SAFETY 22GA 0.9MM OD 25MM L
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·September 16, 2019
BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·September 17, 2019
PKG, NEEDLE HOLDER, CURVED RIGHT, P/N 0250080342. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
CONTAK RENEWAL TR (models H120, H125) and CONTAK RENEWAL TR2 (models H140, H145). CONTAK RENEWAL TR2 devices are not available in the US. Quantities Distributed by model are as follows: CONTAK RENEWAL TR model H120 = 359, model H125 = 235; TR2 model H140 = 613, model H145 = 390.
FDA Recall
Terminated
·Boston Scientific CRM Corp·Product code NKE·June 24, 2006