13 results
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9ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RIO is indicated for use in surgical knee and hip procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include: Unicondylar knee replacement (UKA) and/or Patellofemoral knee replacement (PKA) and Total Hip Arthroplasty (THA).
FDA Enforcement
Class II
·Terminated·Mako Surgical Corporation·November 28, 2012
Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
FDA Recall
Terminated
·Biosite Inc·Product code DKZ·April 27, 2009
Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
FDA Recall
Terminated
·Biosite Inc·Product code DKZ·April 27, 2009
Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
FDA Recall
Terminated
·Biosite Inc·Product code DKZ·April 27, 2009
MAKO PN 204588 Camera 204588 Label With Camera Stand Number ***PN 200294 SN CAM XXX 2011-01.*** Weight 86.2kg.***Class I Equipment. Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995, UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90.*** Manufactured in USA*** MAKO SURGICAL CORP. 2555 Davie Road, Ft. Lauderdale, FL 33317.*** 204589 Robot Arm Label***PN 203999 SN ROB XXX 2011-01.***V 100/120/230 A 9.6/8.0/4.2 Hz 50/60***Weight 39.4kg***Class I Equipment Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995, UL 60601-1:2003 CAN/CSA-C22.2 No. 601-1-M90.***Manufactured in USA***MAKO SURGICAL CORP. 2555 Davie Road, Ft. Lauderdale, FL 33317.*** 204588 Label With Guidance Module Number***PN 201251 SN GUD XXX 2011-01***Weight 51.7kg***Class I Equipment. Conforms to IEC 60601-1/A2: 1995, En 60601-1/A2: 1995, UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90***Manufactured in USA***MAKO SURGICAL CORP. 2555 Davie Road, Ft. Lauderdale, FL 33317.*** THE RIO uses an infra-red camera for the purpose of spatial navigation. This camera is present on the Camera Stand and communicates with the Guidance Module to provide the locations of the tracked instruments (i.e. robotic-arm, patient trackers, probes, etc). The information is then used to provide the virtual representation of the patient anatomy and the tools on the monitor, and provides necessary information to the robotic-arm to ensure proper bone preparation.
FDA Recall
Terminated
·Mako Surgical Corporation·Product code KQM·October 25, 2010
Dasky Disposable Sampling Tube, REF VSM04 (Saliva Collection Kit + VTM), 10 pcs, IVD, Sterile R
FDA Recall
Terminated
·Krishe Inc·Product code QBD·March 11, 2021
Nonin Model 7600B cerebral oximeter pod. Used with the Nonin Model 7600 Regional Oximeter with Equanox Technology and Bluetooth Wireless Technology. Nonin Medical, Inc., 13700 First Avenue North, Plymouth, Minnesota 55441-5443 USA.
FDA Recall
Terminated
·Nonin Medical, Inc·Product code MUD·October 23, 2009
Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack; and SAM ENI MTM04TUBE, containing 1 tube/pack.
FDA Recall
Terminated
·Mercedes Medical, Inc.·Product code QBD·June 10, 2021
RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of RNAstill MTM specimen collection kits: MTM-SW03 with Oropharyngeal swab and MTMSW-05 with Nasopharyngeal swab, packaged 25 specimen collection kits per plastic sleeve. RNAstill Molecular Transport Medium (MTM) safely deactivates pathogens at the point of collection and stabilizes RNA and DNA, allowing safe transport of specimens at ambient temperature from the collection site to the laboratory with no need for dry ice and no need for special containment facilities.
FDA Recall
Terminated
·BASE 10 GENETICS INC·Product code QBD·January 10, 2022
Dasky Disposable Sampling Tube, REF VSM02, Contents: Transport Media - 50, Nasal swab - 50, Package Insert - 1, IVD, CE
FDA Recall
Terminated
·Krishe Inc·Product code QBD·March 11, 2021
Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box.
FDA Recall
Terminated
·Mercedes Medical, Inc.·Product code QBD·June 10, 2021
Centurion-Pelvic PE120 LARGE/MEDIUM PELVIC TRAY PE2200 PELVIC EXAM TRAY PE2200 PELVIC EXAM TRAY PE2400 PELVIC EXAM TRAY PE2515 SMALL GYN EXAM TRAY PE2515 SMALL GYN EXAM TRAY PE2610 PELVIC EXAM TRAY PE2700 ULTRASOUND TRAY PE2700 ULTRASOUND TRAY PE2820 VAG/VIRGIN VAG EXAM TRAY PE2835 PELVIC EXAM TRAY PE2835 PELVIC EXAM TRAY PE2905 HSG TRAY PE2955 7PELVIC EXAM TRAY PE2965 DISPOSABLE PELVIC EXAM TRAY PE2965 DISPOSABLE PELVIC EXAM TRAY PE3125 PELVIC EXAM TRAY PE3195 PELVIC EXAM TRAY PE3285 PELVIC EXAM TRAY PE3360 PELVIC EXAM TRAY W/LIGHT PE3375 PELVIC EXAM TRAY PE3400 MEDIUM GYN EXAM TRAY PE3475 IUD TRAY PE3585 MEDIUM/LARGE PELVIC EXAM TRAY PE860 VAGINAL BLEEDER KIT
FDA Enforcement
Class II
·Terminated·Centurion Medical Products Corporation·February 12, 2020
Centurion-Surgical Tray MNS10255 DELIVERY TRAY MNS10255 DELIVERY TRAY MNS10310 MEATOTOMY TRAY MNS10310 MEATOTOMY TRAY MNS10525 DELIVERY INSTRUMENT TRAY MNS10620 PACEMAKER TRAY MNS10820 ENT/EPISTAXIS KIT MNS10920 PODIATRY NAIL PACK MNS10985 CERCLAGE REMOVAL KIT MNS11020 VAGINAL DELIVERY TRAY MNS11040 OB DELIVERY PROCEDURE PACK MNS11040 OB DELIVERY PROCEDURE PACK MNS11180 CUTDOWN TRAY MNS11380 CYSTO PROCEDURE KIT MNS11415 BIRTHING SET MNS11430 MYELOGRAM TRAY MNS11485 DERM ROOM TRAY MNS11490 VASECTOMY TRAY MNS11490 VASECTOMY TRAY MNS11605 STERILE FLUORO SSP TRAY MNS11720 OCULOPLASTICS INSTRUMENT SET MNS11780 MOHS INSTRUMENT PACK MNS11885 OB BASIC DELIVERY INSTRUMENT TRAY MNS11980 DERMATOLOGY TRAY MNS12045 LINE REPAIR KIT MNS12090 TOENAIL REMOVAL PACK MNS12140 HAND TRAY MNS12175 PACEMAKER TRAY MNS1320 E.N.T. TRAY MNS1445 VASECTOMY MNS1485 NOSEBLEED TRAY MNS1500 JOINT ASPIRATION KIT MNS1500 JOINT ASPIRATION KIT MNS1545 LATEX FREE NASAL HEMORRHAGE SET MNS1555 EPISTAXIS TRAY MNS1900 NOSEBLEED TRAY MNS1990 NASAL KIT MNS2105 EPISTAXIS TRAY MNS2170 NASAL PACKING TRAY MNS2225B MYELOGRAM TRAY MNS2225B MYELOGRAM TRAY MNS2845 U/S, BASIC BIOPSY TRAY MNS2975 ENT EPISTAXIS TRAY MNS3345A PEDIATRIC CUTDOWN TRAY MNS3450 IUD TRAY MNS3490 CHEMO KIT MNS3925 OB INSTRUMENT TRAY MNS4090A MINOR CUTDOWN TRAY MNS4110 THORACOTOMY TRAY MNS4120 NOSEBLEED TRAY MNS4215 OR VAGINAL DELIVERY TRAY MNS4360 BREAST BIOPSY KIT MNS4405 BIOPSY DERMATOLOGY KIT MNS4545 NASAL TRAY MNS4855 WOUND EXPLORATION/DPL TRAY MNS5170 NEONATAL PROCEDURE TRAY MNS5225 RENAL BIOPSY TRAY MNS5272 OB DELIVERY INSTRUMENT TRAY MNS5410 VAG DELIVERY INSTRUMENTS MNS5410 VAG DELIVERY INSTRUMENTS MNS5425 VAGINAL DELIVERY TRAY MNS5511 ARTHROGRAM TRAY MNS5575 OB DELIVERY TRAY MNS5750A VAGINAL DELIVERY SET MNS6025 GU MEATOTOMY MNS6025 GU MEATOTOMY MNS6260 BIOPSY TRAY MNS6285 MINOR PLASTIC SET MNS6395 VAGINAL DELIVERY KIT MNS6405 MULTI-PURPOSE RADIOLOGY TRAY MNS6820 RADIOLOGIST SPINAL TRAY MNS6880 BIOPSY TRAY MNS6985 PERCUTANEOUS CATHETER PLACEMENT TRAY MNS7155 TONGUE TIE KIT MNS7285 BIOPSY KIT- SHAVE MNS7285 BIOPSY KIT- SHAVE MNS7285 BIOPSY KIT- SHAVE MNS7295 BIOPSY KIT - SHAVE/PUNCH COMBO MNS7325 CATHETER REMOVAL TRAY MNS7415 NASAL HEMORRHAGE TRAY MNS7415 NASAL HEMORRHAGE TRAY MNS7575 MINOR TISSUE TRAY MNS7605 BREAST BIOPSY KIT MNS7815 DERMAL PACK MNS7900 C.T. BIOPSY TRAY MNS8010 EPISTAXIS TRAY MNS8445 SPINAL TRAY MNS8445 SPINAL TRAY MNS8475 ED TRACHEOTOMY TRAY MNS8645 BIOPSY KIT MNS8645 BIOPSY KIT MNS8915 BLOOD CULTURE COLLECTION KIT ; CVAD MNS9005 CENTRAL LINE REMOVAL TRAY MNS9106 ULTRASOUND BIOPSY TRAY MNS9106 ULTRASOUND BIOPSY TRAY MNS9170 CUTDOWN TRAY MNS9245 PACEMAKER TRAY MNS9335 IUD TRAY MNS9455 VAGINAL DELIVERY TRAY W/INSTRUMENTS MNS9480 VAGINAL DELIVERY TRAY MNS9480 VAGINAL DELIVERY TRAY MNS9625 TRACHEOSTOMY KIT MNS965 AMNIOCENTESIS TRAY MNS9710 IUD TRAY MNS9765 PORT INSERTION TRAY MNS9780 ARTHROGRAM TRAY MNS9820 OB PACK MNS9835 VAG DELIVERY TRAY MNS9835 VAG DELIVERY TRAY MNS9855 PACEMAKER INSTRUMENT TRAY MNS9870 DR. NELSON MOHS PACK MNS9870 DR. NELSON MOHS PACK MNS9935 CATH LAB INSTRUMENT KIT
FDA Enforcement
Class II
·Terminated·Centurion Medical Products Corporation·February 12, 2020