18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Craniomaxillofacial Distraction System (CMFD)
FDA 510(k)
FDA Class 2
·Neurology
HUMERAL NAIL
FDA UDI
Biomet Orthopedics, LLC·00887868004902·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197511889·Gosset Abdominal Retractor
120mm ...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197074940·Gosset abdominal retractor 140mm
spread...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197074957·Gosset Abdominal Retractor
160 mm...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197074933·Gosset Abdominal Retractor
100mm ...
ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920
FDA 510(k)
FDA Class 1
·Microbiology
MEDILOGAR4, MEDILOGAR12
FDA 510(k)
FDA Class 2
·Cardiovascular
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962112007·MIXTER FORCEPS, 7 1/2", STRONG CVD
FREESTYLE LITE
FDA Adverse Event
Injury
·Product code NBW·October 6, 2011
CAPTURED HIP SCREW 135 DEGREE 4 HOLE PLATE
FDA Adverse Event
Malfunction
·BIOMET TRAUMA·Product code KTT·May 3, 2017
CAPTURED HIP SCREW LAG SCREW
FDA Adverse Event
Malfunction
·BIOMET TRAUMA·Product code KTT·May 3, 2017
OSCILLATING BONE SAW DBL HOSE CONNECTOR
FDA Adverse Event
Malfunction
·SYNTHES OBERDORF·Product code HWE·October 14, 2014
6.5 CANCELLOUS BONE SCREW 30MM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code HWC·June 22, 2011
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 15, 2008
ACCUDRAIN WITH ANTI-REFLUX VALVE
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES PR·Product code JXG·July 8, 2021
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
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