GUIDANCE TO GLOW TRU SPF 35
ZINC OXIDE
GUIDCORP
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1221806 | 1221806 | GUIDEWIRE TECHNOLOGIES, INC. | 1 | N | 2026-01-01 | 26 KEEWAYDIN DR. SALEM NH US 03079 |
| 3013634985 | 3013634985 | GUIDEMIA TECHNOLOGIES, LLC | 1 | N | 2026-01-01 | 6532 University Way Buena Park CA US 90620 |
| 3029960285 | 3029960285 | GUIDESTAR MEDICAL DEVICES INC. | 1 | N | 2026-01-01 | 201-2067 Cadboro Bay Rd Victoria British Columbia CA V8R5G4 |
| 3030896107 | 3030896107 | GUIDED SMILE | 1 | N | 2026-01-01 | 7100 E. Pleasant Valley Rd Suite 150 Independence OH US 44131 |
| 3010052556 | 3010052556 | GUIDEMIA TECHNOLOGIES INC | 1 | N | 2020-04-25 | 5030 Katella Ave Ste 209 Los Alamitos CA US 90720 |
| 3015145507 | 3015145507 | GUIDED SURGICAL SOLUTIONS | 1 | N | 2020-04-25 | 6795 E Tennessee Ave Ste 1-310 Denver CO US 80224 |
| 3015965793 | 3015965793 | GUIDANCE DENTAL SYSTEMS | 1 | Y | 2020-04-25 | 2400 E Cerritos Ave Anaheim CA US 92806 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 30656 | 1200238428 | K902153 | TEFLON COATED GUIDEWIRE | DQX | 1990-07-31 |
| 30656 | 1014672343 | K890959 | GUIDEWIRE | DQX | 1989-09-12 |
| 322195 | 1522624467 | K233056 | EpiZact | FMF | 2023-11-02 |
| 151481 | 1271173641 | K162850 | GuideMia Ortho+ | PNN | 2017-03-24 |
| 285680 | 1271173641 | K162850 | GuideMia Ortho+ | PNN | 2017-03-24 |
| 151481 | 1620716363 | K121466 | GUIDEMIA | LLZ | 2012-05-31 |
| 285680 | 1620716363 | K121466 | GUIDEMIA | LLZ | 2012-05-31 |
| 222114 | 1067313640 | ||||
| 151481 | 1434832377 | ||||
| 151481 | 1593536891 | ||||
| 327981 | 1691712154 | ||||
| 30656 | 1978812237 |
Product Codes Associated With Registrations#
NDC#
PMA#
PG VALITUDE CRT-P, PG VISIONIST CRT-P
GUIDANT CORP.4100 Hamline Avenue Northst. Paul, MN 55112-5798 PMA NumberP030005 Supplement NumberS227 Date Received12/12/2022 Decision Date12/20/2022 Product Code NKE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process ...
VALITUDE™ CRT-P, VALITUDE™ X4 CRT-P, VISIONIST™ CRT-P, VISIONIST™ X4 CRT-P
GUIDANT CORP.4100 Hamline Avenue Northst. Paul, MN 55112-5798 PMA NumberP030005 Supplement NumberS226 Date Received12/07/2022 Decision Date12/14/2022 Product Code NKE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process ...
Accolade Family of s Pacemakers, and Cardiac Resynchronization Therapy Pacemakers (CRT-Ps)
GUIDANT CORP.4100 Hamline Avenue Northst. Paul, MN 55112-5798 PMA NumberP030005 Supplement NumberS225 Date Received10/26/2022 Decision Date12/12/2022 Product Code NKE Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Labe...
PG VALITUDE CRT-P, PG VISIONIST CRT-P
GUIDANT CORP.4100 Hamline Avenue Northst. Paul, MN 55112-5798 PMA NumberP030005 Supplement NumberS224 Date Received10/05/2022 Decision Date10/28/2022 Product Code NKE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process ...
VALITUDE™ CRT-P, VALITUDE X4 CRT-P
GUIDANT CORP.4100 Hamline Avenue Northst. Paul, MN 55112-5798 PMA NumberP030005 Supplement NumberS221 Date Received09/20/2022 Decision Date09/27/2022 Product Code NKE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process ...
PG Valitude CRT-P IS1 EL, PG Valitude CRT-P IS4 EL, PG Visionist CRT-P IS1 EL, PG Visionist CRT-P LV1 EL, PG Visionist C
GUIDANT CORP.4100 Hamline Avenue Northst. Paul, MN 55112-5798 PMA NumberP030005 Supplement NumberS219 Date Received07/21/2022 Decision Date07/27/2022 Product Code NKE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process ...
PG VALITUDE CRT-P, PG VISIONIST CRT-P
GUIDANT CORP.4100 Hamline Avenue Northst. Paul, MN 55112-5798 PMA NumberP030005 Supplement NumberS218 Date Received06/29/2022 Decision Date07/13/2022 Product Code NKE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process ...
U125 VALITUDE™ CRT-P, U128 VALITUDE™ X4 CRT-P, U225 VISIONIST™ CRT-P, U226 VISIONIST™ CRT-P, U228 VISIONIST™ X4 CRT-P
GUIDANT CORP.
VALITUDE™ CRT-P, VALITUDE™ X4 CRT-P, VISIONIST™ CRT-P, VISIONIST™ X4 CRT-P
GUIDANT CORP.
VALITUDE™ CRT-P; VALITUDE X4 CRT-P
GUIDANT CORP.
ACUITY STEERABLE LEAD SYSTEM
GUIDANT CORP.
VALITUDE CRT-P, VISIONIST CRT-P
GUIDANT CORP.
INVIVE, INTUA, VISIONIST, VALITUDE
GUIDANT CORP.
VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4
GUIDANT CORP.
VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, VISIONIST X4 CRT-P
GUIDANT CORP.
VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, VISIONIST X4 CRT-P
GUIDANT CORP.
Contak Renewal TR, Valitude, Invive, and Intua
GUIDANT CORP.
ACUITY Steerable Lead System
GUIDANT CORP.
ACUITY™ Steerable Heart Failure Lead
GUIDANT CORP.
VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, and VISIONIST X4 CRT-P
GUIDANT CORP.
VALITUDE, VALITUDE X4, VISIONIST and VISIONIST X4
GUIDANT CORP.
PG VALITUDE CRT-P and PG VISIONIST CRT-P
GUIDANT CORP.
VALITUDE, VALITUDE X4, VISIONIST, and VISIONIST X4 CRT-P s
GUIDANT CORP.
PG VALITUDE CRT-P, PG VISIONIST CRT-P
GUIDANT CORP.
VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4 - Cardiac Resynchronization Therapy Pacemaker (CRT-P)
GUIDANT CORP.
CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE
GUIDANT CORP.
(CRT-P Resynchronization s) INVIVE, INTUA, VISIONIST, VALITUDE
GUIDANT CORP.
VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, and VISIONIST X4 CRT-P
GUIDANT CORP.
PG VALITUDE CRT-P, PG VISIONIST CRT-P, and INTUA CRT-P
GUIDANT CORP.
PG VALITUDE CRT-P IS1 EL, IS4 EL, PG VISIONIST CRT-P IS1 EL, LV1 EL, IS4 EL
GUIDANT CORP.
Valitude CRT-P, Valitude X4 CRT-P, Visionist CRT-P, and Visionist X4 CRT-P
GUIDANT CORP.
Valitude CRT-P IS1/IS4 EL, Visionist CRT-P IS1 El and Visionist CRT-P LV1 EL
GUIDANT CORP.
Cardiac Resynchronization Therapy - Pacemaker (CRT-P)
GUIDANT CORP.
Valitude, Valitude X4, Visionist, and Visionist X4 Cardiac Resynchronization Therapy - Pacemaker (CRT-P)
GUIDANT CORP.
Visionist and Valitude (CRT-P)
GUIDANT CORP.
INVIVE, INTUA, VISIONIST and VALITUDE CRT-P Resynchronization s
GUIDANT CORP.
Accolade CRT – Pacemakers (CRT-Ps)
GUIDANT CORP.
CRT-P Resynchronization s INVIVE, INTUA, VISIONIST, VALITUDE
GUIDANT CORP.
INVIVE, INTUA, VISIONIST and VALITUDE (CRT-P Resynchronization s)
GUIDANT CORP.
Accolade Cardiac Resynchronization Therapy Pacemakers
GUIDANT CORP.
PMN#
GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500
GUIDANT CORP.
VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002
GUIDANT CORPORATION, CARDIAC SURGERY
RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATHETER, 8F MODEL# 6775, 6777, 6778, 6779, 6780, 6781, 6782,
GUIDANT CORP.
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010
Guidant Corp.
SYNCRUS INTERNAL CARDIOVERSION SYSTEM
GUIDANT CORPORATION, CARDIAC SURGERY
HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE
GUIDANT CORP.
GUIDANT BALLOON CATHETER, SEVERAL MODELS
GUIDANT CORP.
HI-TORQUE EXTRA S'PORT GUIDEWIRE
GUIDANT CORP.
EASYTRAK GUIDING CATHETER
GUIDANT CORP.
MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING
GUIDANT CORP.
VASOVIEW 5 HARVESTING CANNULA
GUIDANT CORPORATION, CARDIAC SURGERY
HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, #1009659,1009659J, 1009660, 10096
GUIDANT CORP.
7MM EXTENDED LENGTH ENDOSCOPE,DISSECTION TIPS, MODELS VH-1111, VH-1114
GUIDANT CORP.
HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
GUIDANT CORP.
MODIFICATION TO VIKING OPTIMA GUIDING CATHETER
GUIDANT CORP.
VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
GUIDANT CORP.
OMNILINK .035 BILIARY STENT SYSTEM
GUIDANT CORP.
AVIATOR PERIPHERAL DILATATION CATHETER
Guidant Corp.
GUIDANT RETRIEVER DEVICE
GUIDANT CARDIAC AND VASCULAR SURGERY
OMNILINK .018 BILIARY STENT SYSTEM
GUIDANT CORP.
RX HERCULINK PLUS BILIARY STENT SYSTEM
GUIDANT CORP.
ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER
GUIDANT CARDIAC AND VASCULAR SURGERY
DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM
GUIDANT CORP.
HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS GUIDE WIRE WITH HYDROCOAT HYDRO
GUIDANT CORP.
VIKING OPTIMA GUIDING CATHETER
GUIDANT CORP.
OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1
GUIDANT CORP.
RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100
GUIDANT CORP.
1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER
GUIDANT CORP.
5F GUIDING CATHETER
GUIDANT CORP.
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER
GUIDANT CORP.
RX VIATRAC 18 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER
GUIDANT CORP.
MODIFICATION TO RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13,
GUIDANT CORP.
LEAD STYLET,MODELS 6505,6506,6507,6508
GUIDANT CORP.
RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIARY STENT SYSTEM
GUIDANT CORP.
COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331
GUIDANT CORP.
GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58
GUIDANT CORP.
HI-TORQUE BALANCE TREK GUIDE WIRE
GUIDANT CORP.
ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING.
GUIDANT CORP.
STANDARD 0.025 STRAIGHT, STANDARD 0.025 ANGLED, STANDARD 0.032 STRAIGHT, STANDARD 0.032 ANGLED, SOFT 0.035 STRAIGHT, SOF
GUIDANT CORP.
ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATING
GUIDANT CORP.
GUDID#
GuidedSMILE - Gasket & Plug Set
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GuidedSMILE - GuidedSMILE Surgical Guide
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GuidedSMILE - CombiGuide Surgical Guide
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GuidedSMILE - Fixation Kit - Short & Long
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GuidedSMILE - Fixation Kit - Long
2024-06-25
GuidedSMILE - Fixation Kit - Short
2024-06-25
GuidedSMILE - Lite Stacking Pin
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GuidedSMILE - Short CHROME Pin
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GuidedSMILE - Long CHROME Pin
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GuidedSMILE - Short CHROME Drill
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GuidedSMILE - Long CHROME Drill
2024-06-25
EpiZact - EpiZact is a single use medical device used during an epidural procedure.
2023-11-30
GuidePro3D - dental implant surgical guide software
2017-01-11