ClearanceBrief
Panels › General, Plastic Surgery › Product code LRO · Class 2

General Surgery Tray

Regulation 878.4370

0510(k)s in 12 months (110 all time)
103recalls in 12 months (1,084 all time)
141recalls that name a 510(k)
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Top companies in LRO

DateFirm and productCodeLinked 510(k)
Jun 22, 2017Avid Medical, Inc.
AVID TruCustom SPINE convenience kits, Item Code: LITT016-04
Terminated
LRONone listed
Jun 22, 2017Avid Medical, Inc.
AVID TruCustom SHOULDER ARTHROSCOPY convenience kits, Item Code: MADN010-02
Terminated
LRONone listed
Jun 22, 2017Avid Medical, Inc.
AVID TruCustom PV MINOR PACK convenience kits, Item Code: MADN017-02 and MADN017-03
Terminated
LRONone listed
Jun 22, 2017Avid Medical, Inc.
AVID TruCustom PLASTIC BASIN PACK convenience kits, Item Code: MADN008-03
Terminated
LRONone listed
Jun 22, 2017Avid Medical, Inc.
AVID TruCustom PACEMAKER PACK (CARDIOLOGY) convenience kits, Item Code: VAMK016
Terminated
LRONone listed
Jun 22, 2017Avid Medical, Inc.
AVID TruCustom PACEMAKER PACK convenience kits, Item Code: LGHM030-06
Terminated
LRONone listed
Jun 22, 2017Avid Medical, Inc.
AVID TruCustom NEURO PK convenience kits, Item Code: LGHM021-08
Terminated
LRONone listed
Jun 22, 2017Avid Medical, Inc.
AVID TruCustom MINOR PROCEDURE 6A convenience kits, Item Code: MADN032-01
Terminated
LRONone listed
Jun 22, 2017Avid Medical, Inc.
AVID TruCustom LOWER EXTREMITY convenience kits, Item Code: LGHM038-03 and LGHM038-04
Terminated
LRONone listed
Jun 22, 2017Avid Medical, Inc.
AVID TruCustom LAMINECTOMY PACK convenience kits, Item Code: MADN013-02
Terminated
LRONone listed
Jun 22, 2017Avid Medical, Inc.
AVID TruCustom KNEE ARTHROSCOPY PACK convenience kits, Item Code: MADN011-02
Terminated
LRONone listed
Jun 22, 2017Avid Medical, Inc.
AVID TruCustom GYN LAPAROSCOPY convenience kits, Item Code: LGHM013-06 and LGHM013-07
Terminated
LRONone listed
Jun 22, 2017Avid Medical, Inc.
AVID TruCustom GENERAL PACK convenience kits, Item Code: LGHM041-06 and LGHM041-08
Terminated
LRONone listed
Jun 22, 2017Avid Medical, Inc.
AVID TruCustom EXTREMITY PACK convenience kits, Item Code: MADN012-01 and MADN012-02
Terminated
LRONone listed
Jun 22, 2017Avid Medical, Inc.
AVID TruCustom ELECTRO PHYSIOLOGY PK convenience kits, Item Code: LGHM033-04
Terminated
LRONone listed
Jun 22, 2017Avid Medical, Inc.
AVID TruCustom CATH PACK convenience kits, Item Code: LGHM036-14
Terminated
LRONone listed
Jun 22, 2017Avid Medical, Inc.
AVID TruCustom ORTHO TRAY convenience kits, Item Code: LGHM004-07 and LGHM004-08
Terminated
LRONone listed
Jun 22, 2017Avid Medical, Inc.
AVID TruCustom HEART CATH TRAY convenience kits, Item Code: LAKC022-06
Terminated
LRONone listed
Jun 22, 2017Avid Medical, Inc.
AVID TruCustom PACEMAKER TRAY convenience kits, Item Code: LAKC020-08 and LAKC020-09
Terminated
LRONone listed
Jun 22, 2017Avid Medical, Inc.
AVID TruCustom OBSTETRICAL PACK convenience kits, Item Code: HLDH008-04
Terminated
LRONone listed
Jun 22, 2017Avid Medical, Inc.
AVID TruCustom DJ'S VASCULAR/NEURO TRAY convenience kits, Item Code: AV010930-12
Terminated
LRONone listed
Jun 22, 2017Avid Medical, Inc.
AVID TruCustom DAVINCI PACK convenience kits, Item Code: ADVU037-09
Terminated
LRONone listed
Jan 25, 2017DeRoyal Industries Inc
SRHS DeRoyal Heart Tracecart REF 53-1913, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.
Terminated
LRONone listed
Jan 25, 2017DeRoyal Industries Inc
DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.
Terminated
LROK842648
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800326002, Sterile, GS0757B - Major Basin - OSU
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800036004, Sterile, LD0274D - C Section Pack - FMOL St Francis
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 880327006, Sterile, CV0758F - Open Heart A&B - OSU
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800568002, Sterile, OR0658 - Titanium Rib - Childrens Santa Rosa
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800533001, Sterile, GS0606A - Abdominal Pk - Westover Hills
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800562001, Sterile, NU0651A - Neuro - Childrens Santa Rosa
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800430005, Sterile, LD0499E - C Section Pk - Cabrini
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800430004, Sterile, LD0499D - C Section Pk - Cabrini
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800508003, Sterile, LD0586C - C Section - Jasper
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800508002, Sterile, LD0586B - C Section - Jasper
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800425002, Sterile, CV0494B - AV Access Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800425001, Sterile, CV0494A - AV Access Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800422004, Sterile, OR0491D - Arthroscopy Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800422003, Sterile, OR0491C - Arthroscopy Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800419002, Sterile, GY0488B - D&C Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800419001, Sterile, GY0488A - D&C Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800418003, Sterile, GY0487C - Major Vaginal Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800418002, Sterile, GY0487B - Major Vaginal Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800417002, Sterile, GY0486B - Laparoscopy Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800416002, Sterile, GY0485B - Robotic Hysterectomy Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800416001, Sterile, GY0485A - Robotic Hysterectomy Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800415003, Sterile, OR0484C- Shoulder System Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800415002, Sterile, OR0484B- Shoulder System Pk - Spohn
Terminated
LRONone listed

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