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Intuitive Surgical, Inc.

218 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
da Vinci S / Si Surgical System IS2000 / IS3000, Camera Arm Drape, 20 Pack. Microtek Medic recall (Z-1388-2015)Intuitive Surgical, Inc.2015-04-06
da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medic recall (Z-1389-2015)Intuitive Surgical, Inc.2015-04-06
da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medic recall (Z-1390-2015)Intuitive Surgical, Inc.2015-04-06
da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment recall (Z-1391-2015)Intuitive Surgical, Inc.2015-04-06
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medi recall (Z-1392-2015)Intuitive Surgical, Inc.2015-04-06
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medi recall (Z-1393-2015)Intuitive Surgical, Inc.2015-04-06
da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Material number: 3806 recall (Z-1302-2015)Intuitive Surgical, Inc.2015-03-20
da Vinci Xi Surgical System, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000, Material number: 380663 recall (Z-1303-2015)Intuitive Surgical, Inc.2015-03-20
da Vinci Xi Surgical System, IS4000; ASSY,USM,IS4000, Material number: 380647-20 and 38064 recall (Z-1304-2015)Intuitive Surgical, Inc.2015-03-20
Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS30 recall (Z-1226-2015)Intuitive Surgical, Inc.2015-02-27
EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci Surgical recall (Z-1141-2015)Intuitive Surgical, Inc.2015-02-24
EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Sur recall (Z-1142-2015)Intuitive Surgical, Inc.2015-02-24
HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci St recall (Z-1117-2015)Intuitive Surgical, Inc.2015-02-13
HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use with the da V recall (Z-1118-2015)Intuitive Surgical, Inc.2015-02-13
da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intende recall (Z-1048-2015)Intuitive Surgical, Inc.2015-02-03
IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3 recall (Z-0940-2015)Intuitive Surgical, Inc.2015-01-07
Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for recall (Z-0834-2015)Intuitive Surgical, Inc.2014-12-19
Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for recall (Z-0835-2015)Intuitive Surgical, Inc.2014-12-19
8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endos recall (Z-0427-2015)Intuitive Surgical, Inc.2014-11-25
8MM,LARGE NEEDLE DRIVER; Intended to assist in the accurate control of Intuitive Surgical recall (Z-0428-2015)Intuitive Surgical, Inc.2014-11-25
8MM,BLACK DIAMOND MICRO FORCEPS; Intended to assist in the accurate control of Intuitive S recall (Z-0429-2015)Intuitive Surgical, Inc.2014-11-25
8MM,LONG TIP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical End recall (Z-0430-2015)Intuitive Surgical, Inc.2014-11-25
8MM,MICRO BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgica recall (Z-0431-2015)Intuitive Surgical, Inc.2014-11-25
8MM,PROGRASP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical End recall (Z-0432-2015)Intuitive Surgical, Inc.2014-11-25
8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surg recall (Z-0433-2015)Intuitive Surgical, Inc.2014-11-25
8MM MONOPOLAR CURVED SCISSORS; Intended to assist in the accurate control of Intuitive Sur recall (Z-0434-2015)Intuitive Surgical, Inc.2014-11-25
8MM RESANO FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endo recall (Z-0435-2015)Intuitive Surgical, Inc.2014-11-25
8MM PERMANENT CAUTERY HOOK,; Intended to assist in the accurate control of Intuitive Surgi recall (Z-0436-2015)Intuitive Surgical, Inc.2014-11-25
8MM PERMANENT CAUTERY SPATULA,; Intended to assist in the accurate control of Intuitive Su recall (Z-0437-2015)Intuitive Surgical, Inc.2014-11-25
8MM FENESTRATED BIPOLAR FORCEPS,; Intended to assist in the accurate control of Intuitive recall (Z-0438-2015)Intuitive Surgical, Inc.2014-11-25
8MM, TENACULUM FORCEPS; Intended to assist in the accurate control of Intuitive Surgical E recall (Z-0439-2015)Intuitive Surgical, Inc.2014-11-25
8MM, CARDIAC PROBE GRASPER; Intended to assist in the accurate control of Intuitive Surgic recall (Z-0440-2015)Intuitive Surgical, Inc.2014-11-25
8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate control of Intuitive recall (Z-0441-2015)Intuitive Surgical, Inc.2014-11-25
8MM, ATRIAL RETRACTOR SHORT RIGHT ; Intended to assist in the accurate control of Intuitiv recall (Z-0442-2015)Intuitive Surgical, Inc.2014-11-25
8MM, DUAL BLADE RETRACTOR; Intended to assist in the accurate control of Intuitive Surgica recall (Z-0443-2015)Intuitive Surgical, Inc.2014-11-25
8MM, MEGA SUTURECUT ND; Intended to assist in the accurate control of Intuitive Surgical E recall (Z-0444-2015)Intuitive Surgical, Inc.2014-11-25
8MM, SMALL GRASPING RETRACTOR ; Intended to assist in the accurate control of Intuitive Su recall (Z-0445-2015)Intuitive Surgical, Inc.2014-11-25
8MM,MEDIUM-LARGE CLIP APPLIER ; Intended to assist in the accurate control of Intuitive Su recall (Z-0446-2015)Intuitive Surgical, Inc.2014-11-25
8MM, CURVED BIPOLAR DISSECTOR; Intended to assist in the accurate control of Intuitive Sur recall (Z-0447-2015)Intuitive Surgical, Inc.2014-11-25
8MM, TIP-UP FENESTRATED GRASPER; Intended to assist in the accurate control of Intuitive S recall (Z-0448-2015)Intuitive Surgical, Inc.2014-11-25
EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product Us recall (Z-0074-2015)Intuitive Surgical, Inc.2014-10-16
EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS300 recall (Z-0063-2015)Intuitive Surgical, Inc.2014-10-10
ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System. Product Usa recall (Z-2731-2014)Intuitive Surgical, Inc.2014-09-30
EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWrist Stapler 45 Sys recall (Z-2171-2014)Intuitive Surgical, Inc.2014-08-08
Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S recall (Z-2020-2014)Intuitive Surgical, Inc.2014-07-08
Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Int recall (Z-1994-2014)Intuitive Surgical, Inc.2014-07-04
System Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si recall (Z-1964-2014)Intuitive Surgical, Inc.2014-07-02
Endowrist Instrument and Accessory Manual for the da Vinci Standard Surgical System; da Vi recall (Z-1965-2014)Intuitive Surgical, Inc.2014-07-02
Vision Troubleshooting Guide for the da Vinci Standard Surgical System; da Vinci S System recall (Z-1966-2014)Intuitive Surgical, Inc.2014-07-02
Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da Vinci S recall (Z-1967-2014)Intuitive Surgical, Inc.2014-07-02
Stapler Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci recall (Z-1968-2014)Intuitive Surgical, Inc.2014-07-02
Vessel Sealer Addendum for the da Vinci Standard Surgical System; da Vinci S System and da recall (Z-1969-2014)Intuitive Surgical, Inc.2014-07-02
Vessel Sealer QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinc recall (Z-1970-2014)Intuitive Surgical, Inc.2014-07-02
Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard Surgical Syst recall (Z-1971-2014)Intuitive Surgical, Inc.2014-07-02
IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si Syste recall (Z-1972-2014)Intuitive Surgical, Inc.2014-07-02
Cautery QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si S recall (Z-1973-2014)Intuitive Surgical, Inc.2014-07-02
Connection QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci S recall (Z-1974-2014)Intuitive Surgical, Inc.2014-07-02
Natural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinci S System and recall (Z-1975-2014)Intuitive Surgical, Inc.2014-07-02
IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. Intuitive Surgical Inc recall (Z-1870-2014)Intuitive Surgical, Inc.2014-06-25
IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc. recall (Z-1871-2014)Intuitive Surgical, Inc.2014-06-25
Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical recall (Z-1718-2014)Intuitive Surgical, Inc.2014-06-04
5X300 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS300 recall (Z-1332-2014)Intuitive Surgical, Inc.2014-04-04
5X300 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS300 recall (Z-1333-2014)Intuitive Surgical, Inc.2014-04-04
5X250 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS300 recall (Z-1334-2014)Intuitive Surgical, Inc.2014-04-04
5X250 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS300 recall (Z-1335-2014)Intuitive Surgical, Inc.2014-04-04
Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufac recall (Z-0520-2014)Intuitive Surgical, Inc.2013-12-16
Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufa recall (Z-0521-2014)Intuitive Surgical, Inc.2013-12-16
Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S Surgical Syste recall (Z-0436-2014)Intuitive Surgical, Inc.2013-12-03
Patient Cart used in conjunction with the da Vinci S surgical and SI System. Intuitive Sur recall (Z-0139-2014)Intuitive Surgical, Inc.2013-11-04
da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000; Y1903 recall (Z-0146-2014)Intuitive Surgical, Inc.2013-11-04
Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitiv recall (Z-0110-2014)Intuitive Surgical, Inc.2013-10-30
Single Site Curved Needed Driver Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Su recall (Z-0111-2014)Intuitive Surgical, Inc.2013-10-30
da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high recall (Z-0088-2014)Intuitive Surgical, Inc.2013-10-28
da Vinci Si Surgeon Side Cart, model number SS3000; Manufactured by Intuitive Surgical, Su recall (Z-1686-2013)Intuitive Surgical, Inc.2013-07-11
da Vinci Si Vision System Cart, model number VS3000; Manufactured by Intuitive Surgical, S recall (Z-1687-2013)Intuitive Surgical, Inc.2013-07-11
da Vinci Dual Camera Controller, model number DC3000; Manufactured by Intuitive Surgical, recall (Z-1688-2013)Intuitive Surgical, Inc.2013-07-11
da Vinci Instrument Control Box, model number ICB3000; Manufactured by Intuitive Surgical, recall (Z-1689-2013)Intuitive Surgical, Inc.2013-07-11
da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Use recall (Z-1463-2013)Intuitive Surgical, Inc.2013-06-05
da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Syste recall (Z-1464-2013)Intuitive Surgical, Inc.2013-06-05
8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distributed by: Intuit recall (Z-1442-2013)Intuitive Surgical, Inc.2013-05-31
User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Prod recall (Z-1424-2013)Intuitive Surgical, Inc.2013-05-29
Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessor recall (Z-1425-2013)Intuitive Surgical, Inc.2013-05-29
Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroi recall (Z-1426-2013)Intuitive Surgical, Inc.2013-05-29
Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or recall (Z-1427-2013)Intuitive Surgical, Inc.2013-05-29
Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument. recall (Z-1428-2013)Intuitive Surgical, Inc.2013-05-29
da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgi recall (Z-1429-2013)Intuitive Surgical, Inc.2013-05-29
8mm Precise Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model I recall (Z-1431-2013)Intuitive Surgical, Inc.2013-05-29
8mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model recall (Z-1432-2013)Intuitive Surgical, Inc.2013-05-29
8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci Surgical System, Mod recall (Z-1433-2013)Intuitive Surgical, Inc.2013-05-29
IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm dr recall (Z-1109-2013)Intuitive Surgical, Inc.2013-04-13
IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Su recall (Z-1110-2013)Intuitive Surgical, Inc.2013-04-13
Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Bo recall (Z-2339-2012)Intuitive Surgical, Inc.2012-09-10
INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use of the Instrument ar recall (Z-2101-2012)Intuitive Surgical, Inc.2012-07-27
KIT,DISPOSABLE ACCESSORY,3ARM,IS2000,5 PACK; Product Usage: The intended use of the Instru recall (Z-2102-2012)Intuitive Surgical, Inc.2012-07-27
KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK; Product Usage: The intended use of the Instru recall (Z-2103-2012)Intuitive Surgical, Inc.2012-07-27
KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intended use of the Instru recall (Z-2104-2012)Intuitive Surgical, Inc.2012-07-27
KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK; Product Usage: The intended use of the Instru recall (Z-2105-2012)Intuitive Surgical, Inc.2012-07-27
ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of the Instrument arm d recall (Z-2106-2012)Intuitive Surgical, Inc.2012-07-27
da Vinci S. Surgical System, da Vinci Si and da Vinci Si-e Surgical Systems. Intuitive Sur recall (Z-1202-2012)Intuitive Surgical, Inc.2012-03-13
Intuitive Surgical da Vinci Si Surgical System (IS3000); Mfg by: Intuitive Surgical, Sunny recall (Z-2930-2011)Intuitive Surgical, Inc.2011-08-03
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Every clearance here is in the API, with alerts when new ones post.