Instrument, Cranioplasty Material Forming
Neurology · 21 CFR 882.4500
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
3 recall events for this product code
- DePuy Mitek, Inc., a Johnson & Johnson Co.TerminatedApr 12, 2011
DePuy Mitek FMS Irrigation Intermediary Tube With One-way Valve Arthroscopy tubing
Product sterility may be compromised due to breach in sterile packaging
Z-1946-2011 · View FDA record ↗ - DePuy Mitek, Inc., a Johnson & Johnson Co.TerminatedApr 12, 2011
DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing
Product sterility may be compromised due to breach in sterile packaging
Z-1947-2011 · View FDA record ↗ - DePuy Mitek, Inc., a Johnson & Johnson Co.TerminatedApr 12, 2011
DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing (100 units/box)
Product sterility may be compromised due to breach in sterile packaging
Z-1948-2011 · View FDA record ↗
Registered firms
11 firms currently registered for this product code
Changzhou Geasure Medical Apparatus And Instruments Co., Ltd
Changzhou Jiangsu, CN
Falcon Surgical Co. (pvt.) Ltd.
Sialkot Punjab, PK
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Clariance, Inc.
Dallas, TX, US
Deroyal Industries, Inc.
POWELL, TN, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Deroyal Intercontinental, S.r.l.
SANTIAGO, DO
Gesco Healthcare Private Limited
CHENNAI, Tamil Nadu, IN
Clariance-sas
BEAURAINS Hauts-de-France, FR
Synthes (usa) Products Llc
West Chester, PA, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.