14 results
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20ms
·
Sources: EU EUDAMED, US FDA
FMRI HARDWARE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526827875·***DISC*LEVAMED ANKLE SUPPORT BLACK V
iTotal TIBIAL TACK PIN
FDA UDI
Conformis, Inc.·00810933030278·
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014606200·ALLEN ULTRA FIN REPLACEMENT BOOT PAD SET
Track E
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR4080515·Track E ø 1,5 x 125 mm
Clamp, Hysterectomy, model Z 24cm shanks angled
FDA UDI
Geister Medizintechnik GmbH·04057034373163·Clamp, Hysterectomy, model Z
24cm s...
MODIFICATION TO SYNERGY SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,
FDA 510(k)
FDA Class 2
·Orthopedic
ASAHI REXEED-LX SERIES DIALYZER
FDA Adverse Event
Injury
·ASAHI KASEI MEDICAL CO., LTD.·Product code KDI·May 4, 2012
BRILLIANCE 64
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.·Product code JAK·April 24, 2013
SINGLE EXTENSION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·April 22, 2011
HS HAND CONTROLLED CURVED SHEA
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GEI·July 24, 2008
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
FDA Enforcement
Class II
·Terminated·Care Essentials Pty., Ltd.·February 12, 2020
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024