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Resource Optimization & Innovation Llc

88 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays c recall (Z-0229-2016)Resource Optimization & Innovation Llc2015-11-05
Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery. recall (Z-0184-2016)Resource Optimization & Innovation Llc2015-10-30
Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardiovascular s recall (Z-0185-2016)Resource Optimization & Innovation Llc2015-10-30
Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for cardiov recall (Z-0186-2016)Resource Optimization & Innovation Llc2015-10-30
Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for cardiov recall (Z-0187-2016)Resource Optimization & Innovation Llc2015-10-30
Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical kit for cardiov recall (Z-0188-2016)Resource Optimization & Innovation Llc2015-10-30
Regard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical kit for surger recall (Z-0189-2016)Resource Optimization & Innovation Llc2015-10-30
Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical kit for card recall (Z-0190-2016)Resource Optimization & Innovation Llc2015-10-30
Regard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical kit for surgery recall (Z-0191-2016)Resource Optimization & Innovation Llc2015-10-30
regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover li recall (Z-0028-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light recall (Z-0029-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit containing cover lig recall (Z-0030-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover recall (Z-0031-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover recall (Z-0032-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800410, Sterile, CV0479 - Open Heart Pk - surgical kit containing cove recall (Z-0033-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800411, Sterile, NU0480 - Neuro Pk - surgical kit containing cover lig recall (Z-0034-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800413, Sterile, CV0482 - Vascular Pk - surgical kit containing cover recall (Z-0035-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800414, Sterile, OR0483 - Total Joint Pk - surgical kit containing cov recall (Z-0036-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800415, Sterile, OR0484 - Shoulder System Pk - surgical kit containing recall (Z-0037-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800416, Sterile, GY0485 - Robotic Hysterectomy Pkg - surgical kit cont recall (Z-0038-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800417, Sterile, GY0486 - Laparoscopy Pk - surgical kit containing cov recall (Z-0039-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800418, Sterile, GY0487 - Major Vaginal Pk - surgical kit containing c recall (Z-0040-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800419, Sterile, GY0488 - D&C Pk - surgical kit containing cover light recall (Z-0041-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800422, Sterile, OR0491 - Arthroscopy Pk - surgical kit containing cov recall (Z-0042-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800425, Sterile, CV0494 - AV Access Pk -Spohn surgical kit containing recall (Z-0043-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800508, Sterile, LD0586 - C Section - surgical kit containing cover li recall (Z-0044-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800514, Sterile, LD0592 - C Section Pack - surgical kit containing cov recall (Z-0045-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800524, Sterile, LD0608 - C Section - surgical kit containing cover li recall (Z-0046-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800525, Sterile, OR0609 - Extremity Pack - surgical kit containing cov recall (Z-0047-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800526, Sterile, ET0610 - Head and Neck - surgical kit containing cove recall (Z-0048-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800527, Sterile, OR0611 - Hip Shoulder Pk - surgical kit containing co recall (Z-0049-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800528, Sterile, GS0612 - Lap Chole Pk - surgical kit containing cover recall (Z-0050-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800531, Sterile, NU0615 - Neuro Pk - surgical kit containing cover lig recall (Z-0051-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800532, Sterile, GY0616 - Vaginal Hysterectomy - surgical kit containi recall (Z-0052-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800533, Sterile, GS0606 - Abdominal Pk - surgical kit containing cover recall (Z-0053-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800535, Sterile, LD0620 - C Section - surgical kit containing cover li recall (Z-0054-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800546, Sterile, GS0635 - Abdominal - surgical kit containing cover li recall (Z-0055-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800548, Sterile, OR0637 - Extremity - surgical kit containing cover li recall (Z-0056-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800549, Sterile, ET0638 - Head & Neck - surgical kit containing cover recall (Z-0057-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800550, Sterile, OR0639 - Hip Shoulder - surgical kit containing cover recall (Z-0058-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800551, Sterile, GS0640 - Lap Chole - surgical kit containing cover li recall (Z-0059-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800553, Sterile, OR0642 - Total Knee - surgical kit containing cover l recall (Z-0060-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800554, Sterile, GS0643 - Pediatric Basic - surgical kit containing co recall (Z-0061-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800555, Sterile, HT0644 - Pediatric Card Cath - surgical kit containin recall (Z-0062-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800557, Sterile, LD0646 - C-Section - surgical kit containing cover li recall (Z-0063-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800558, Sterile, OR0647 - Extremity - surgical kit containing cover li recall (Z-0064-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800559, Sterile, ET0648 - Head & Neck - surgical kit containing cover recall (Z-0065-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800560, Sterile, GS0649 - Lap Chole - surgical kit containing cover li recall (Z-0066-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800562, Sterile, NU0651 - Neuro - surgical kit containing cover light recall (Z-0067-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800565, Sterile, CV0654 - Pediatric Heart - surgical kit containing co recall (Z-0068-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800566, Sterile, NU0655 - VP Shunt - surgical kit containing cover lig recall (Z-0069-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800567, Sterile, GY0656 - Robotic Hysterectomy - surgical kit containi recall (Z-0070-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800568, Sterile, OR0658 - Titanium Rib - surgical kit containing cover recall (Z-0071-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800569, Sterile, CV0659 - Open Heart A & B - surgical kit containing c recall (Z-0072-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800597, Sterile, GY0688 - LAVH - surgical kit containing cover light h recall (Z-0073-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800599, Sterile, GS0694 - Robotic Lap - surgical kit containing cover recall (Z-0074-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800615, Sterile, CV0741 - Peripheral Vascular - surgical kit containin recall (Z-0075-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800617, Sterile, NU0768 - Neuro Pk - surgical kit containing cover lig recall (Z-0076-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800623, Sterile, NU0787 - Neuro - surgical kit containing light handle recall (Z-0077-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 880321, Sterile, GS0752 - Breast Pk - surgical kit containing cover li recall (Z-0078-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 880323, Sterile, LD0754 - C Section - surgical kit containing cover li recall (Z-0079-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 880326, Sterile, GS0757 - Major Basin - surgical kit containing cover recall (Z-0080-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 880327, Sterile, CV0758 - Open Heart A&B - surgical kit containing cov recall (Z-0081-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 880328, Sterile, HT0759 - Pacemaker Pk - surgical kit containing cover recall (Z-0082-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 880330, Sterile, OR0761 - Total Hip - surgical kit containing cover li recall (Z-0083-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 880331, Sterile, OR0762 - Total Knee - surgical kit containing cover l recall (Z-0084-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800036002, Sterile, LD0274B - C Section Pack - surgical kit containing recall (Z-0085-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800036003, Sterile, LD0274C - C Section Pack - surgical kit containing recall (Z-0086-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800091001, Sterile, LD0692A - C Section - surgical kit containing cove recall (Z-0087-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800407001, Sterile, OR0476A - Ortho Pk - surgical kit containing cover recall (Z-0088-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800408001, Sterile, LD0477A - C-Section Pk - surgical kit containing c recall (Z-0089-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800410001, Sterile, CV0479A - Open Heart Pk - surgical kit containing recall (Z-0090-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800411001, Sterile, NU0480A - Neuro Pk - surgical kit containing cover recall (Z-0091-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800411002, Sterile, NU0480B - Neuro Pk - surgical kit containing cover recall (Z-0092-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800413001, Sterile, CV0482A - Vascular Pk - surgical kit containing co recall (Z-0093-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800422001, Sterile, OR0491A - Arthroscopy Pk - surgical kit containing recall (Z-0094-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800524001, Sterile, LD0608A - C Section - surgical kit containing cove recall (Z-0095-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800528001, Sterile, GS0612A - Lap Chole Pk - surgical kit containing c recall (Z-0096-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800554001, Sterile, GS0643A - Pediatric Basic - surgical kit containin recall (Z-0097-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800554002, Sterile, GS0643B - Pediatric Basic - surgical kit containin recall (Z-0098-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800560001, Sterile, GS0649A - Lap Chole - surgical kit containing cove recall (Z-0099-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number 800565001, Sterile, CV0654A - Pediatric Heart - surgical kit containing recall (Z-0100-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number 800567001, Sterile, GY0656A - Robotic Hysterectomy - surgical kit conta recall (Z-0101-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number 800568001, Sterile, OR0658A - Titanium Rib - surgical kit containing co recall (Z-0102-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 800569001, Sterile, CV0659A - Open Heart A&B - surgical kit containing recall (Z-0103-2016)Resource Optimization & Innovation Llc2015-10-07
regard Item Number: 880327002, sterile, CV0758B - Open Heart A&B - surgical kit containing recall (Z-0104-2016)Resource Optimization & Innovation Llc2015-10-07
Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardio recall (Z-2798-2015)Resource Optimization & Innovation Llc2015-09-21
Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used in recall (Z-2799-2015)Resource Optimization & Innovation Llc2015-09-21

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Every clearance here is in the API, with alerts when new ones post.