11 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496060536·CURVY 70 OPAQUE, SIZE S-XL, MOKA, GRADUATED COM...
Logical Lateralised 20° Hooded Liner
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215095369·
SYNTHES ANTERIOR CSLP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
FDA 510(k)
FDA Class 2
·Microbiology
8 CM HEAVY DUTY MEDIUM ATTACHMENT
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·April 10, 2013
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTL. LTD.·Product code KWA·April 6, 2011
GYNECARE X-TRACT MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·June 12, 2008
TI CERVICAL SPINE LOCKING PLATE 45MM (37MM)
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWQ·September 9, 2015
enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120). The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.
FDA Enforcement
Class II
·Terminated·Vital Signs Devices, a GE Healthcare Company·July 18, 2012
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026