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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 19 Results
510(K) Number: K203790
 
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Product Description
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FDA Recall
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GEM Premier 5000; Part No: 00055415011. 2 03/10/2026 FEI # 1217183
Instrumentation Laboratory
GEM Premier 5000; Part No. 00055445010 & 00055445011. 2 03/10/2026 FEI # 1217183
Instrumentation Laboratory
GEM Premier 5000; Part No. 00055445008. 2 03/10/2026 FEI # 1217183
Instrumentation Laboratory
GEM Premier 5000; Part No. 00055445004. 2 03/10/2026 FEI # 1217183
Instrumentation Laboratory
GEM Premier 5000; Part No. 00055430011. 2 03/10/2026 FEI # 1217183
Instrumentation Laboratory
GEM Premier 5000; Part No. 00055430008. 2 03/10/2026 FEI # 1217183
Instrumentation Laboratory
GEM Premier 5000; Part No. 00055430004. 2 03/10/2026 FEI # 1217183
Instrumentation Laboratory
GEM Premier 5000; Part No. 00055415008. 2 03/10/2026 FEI # 1217183
Instrumentation Laboratory
GEM Premier 5000; Part No. 00055415005. 2 03/10/2026 FEI # 1217183
Instrumentation Laboratory
GEM Premier 5000; Model No. 00055430010. 2 03/10/2026 FEI # 1217183
Instrumentation Laboratory
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