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#
EpiZact
Guidestar Medical Devices
GuideMia Ortho+
GUIDEMIA TECHNOLOGIES, LLC
CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF)
GUIDEPATH MEDICAL, INC.
GUIDEMIA
GUIDEMIA TECHNOLOGIES, LLC
GDS-DC12
GUIDED DELIVERY SYSTEMS
GDS-DCS
GUIDED DELIVERY SYSTEMS
HEARTSTRING III PROXIMAL SEAL SYSTEM
GUIDANT CORPORATION, CARDIAC SURGERY
FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05
GUIDANT CORP.
HI-TORQUE WHISPER VIEW GUIDE WIRE
GUIDANT CORP.
OMNILINK. 018 BILIARY STENT SYSTEM
GUIDANT ENDOVASCULAR SOLUTIONS, INC.
HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE
GUIDANT CORPORATION
OMNILINK .035 BILIARY STENT SYSTEM
GUIDANT CORPORATION
RX HERCULINK ELITE BILIARY STENT SYSTEM
GUIDANT CORPORATION
ACUITY STEERABLE STYLET ACCESSORY
GUIDANT CORPORATION
EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832.
GUIDANT CORPORATION
GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000
GUIDANT CORPORATION
MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM
GUIDANT CORPORATION
RX ACCUNET EMBOLIC PROTECTION SYSTEM
GUIDANT CORPORATION
RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM
GUIDANT CORP.
ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM
GUIDANT CORP.
GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSORY PACK, MODEL VH-2004
GUIDANT CORPORATION
FINISHING WIRE SUPPORTRAK
GUIDANT CORPORATION
GUIDANT MICROWAVE ABLATION SYSTEM
GUIDANT CORPORATION, CARDIAC SURGERY
CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020
GUIDANT CORPORATION
RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568
GUIDANT CORPORATION
OMNILINK .018 BILIARY STENT SYSTEM
GUIDANT CORP.
ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM
GUIDANT CORP.
MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEM
GUIDANT CORPORATION
HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
GUIDANT CORP.
RAPIDO CUT-AWAY CUTTER
GUIDANT CORP.
RAPIDO CUT-AWAY GUIDING CATHETER
GUIDANT CORPORATION
GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM
GUIDANT CORP.
HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE PILOT 150 GUIDE WIRE WITH HYDROCOAT HYDROPHG
GUIDCORP
GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM
GUIDANT CORPORATION, CARDIAC SURGERY
MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE
GUIDANT CORP.
AGILTRAC .035 PERIPHERAL DILATATION CATHETER
GUIDANT CORP.
ESSEX ENDOSCOPE, MODEL SXD-1000
GUIDANT CORP.
ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200
Guidant Corporation, Cardiac Surgery
HI-TORQUE WHISPER LS; HI-TORQUE WHISPER MS; HI-TORQUE WHISPER MS CS-J; HI-TORQUE WHISPER ES; HI-TORQUE WHISPER ES CS-J
GUIDANT CORP.
AGILTRAC .035 PERIPHERAL DILATATION CATHETER
GUIDANT CORP.
GUDID#
GuidedSMILE - Gasket & Plug Set
2024-07-09
GuidedSMILE - GuidedSMILE Surgical Guide
2024-07-09
GuidedSMILE - CombiGuide Surgical Guide
2024-07-09
GuidedSMILE - Fixation Kit - Short & Long
2024-06-25
GuidedSMILE - Fixation Kit - Long
2024-06-25
GuidedSMILE - Fixation Kit - Short
2024-06-25
GuidedSMILE - Lite Stacking Pin
2024-06-25
GuidedSMILE - Short CHROME Pin
2024-06-25
GuidedSMILE - Long CHROME Pin
2024-06-25
GuidedSMILE - Short CHROME Drill
2024-06-25
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