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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for 87-Orthopedic


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-0866624-3/1/1 08-Mar-2011 87HWC 3004359396 Intai Technology Inc. Taiwan
 
112-0751409-7/1/1 02-Mar-2011 87JDS 3004889950 Straits Orthopaedics (mfg) Sdn Bhd Malaysia
 
275-1435124-9/3/9 16-Mar-2011 87JWH 6078 Aesculap Werk Aktiengesellschaft Germany
 
275-1435124-9/3/8 16-Mar-2011 87JWH 6078 Aesculap Werk Aktiengesellschaft Germany
 
275-1435124-9/3/11 16-Mar-2011 87JWH 6078 Aesculap Werk Aktiengesellschaft Germany
 
275-1435124-9/3/10 16-Mar-2011 87JWH 6078 Aesculap Werk Aktiengesellschaft Germany
 
112-0751579-7/1/1 02-Mar-2011 87KTT 3004889950 Straits Orthopaedics (mfg) Sdn Bhd Malaysia
 
275-1435124-9/3/16 16-Mar-2011 87KTT 6078 Aesculap Werk Aktiengesellschaft Germany
 
275-1435124-9/3/15 16-Mar-2011 87KTT 6078 Aesculap Werk Aktiengesellschaft Germany
 
112-1213496-4/1/1 25-Mar-2011 87KTT 3004889950 Straits Orthopaedics (mfg) Sdn Bhd Malaysia
 
275-1435124-9/3/4 16-Mar-2011 87LWJ 6078 Aesculap Werk Aktiengesellschaft Germany
 
275-1435124-9/3/7 16-Mar-2011 87LWJ 6078 Aesculap Werk Aktiengesellschaft Germany
 
275-1435124-9/3/5 16-Mar-2011 87LWJ 6078 Aesculap Werk Aktiengesellschaft Germany
 
275-1435124-9/3/3 16-Mar-2011 87LWJ 6078 Aesculap Werk Aktiengesellschaft Germany
 
275-1435124-9/3/6 16-Mar-2011 87LWJ 6078 Aesculap Werk Aktiengesellschaft Germany
 
112-0721771-7/1/1 17-Mar-2011 87LXH 3008748669 Samay Surgical India
 
275-1435124-9/3/1 16-Mar-2011 87MEH 6078 Aesculap Werk Aktiengesellschaft Germany
 
275-1435124-9/3/2 16-Mar-2011 87MEH 6078 Aesculap Werk Aktiengesellschaft Germany
 
275-1435124-9/3/12 16-Mar-2011 87MJO 6078 Aesculap Werk Aktiengesellschaft Germany
 
275-1435124-9/3/14 16-Mar-2011 87MJO 6078 Aesculap Werk Aktiengesellschaft Germany
 
275-1435124-9/3/13 16-Mar-2011 87MJO 6078 Aesculap Werk Aktiengesellschaft Germany
 
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