Life is healed
Dimethicone
APOLLO
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3006190476 | 3006190476 | APOLLO MEGASUN LLC | 1 | N | 2026-01-01 | 4515 MIAMI ST Saint Louis MO US 63116 |
| 3010032115 | 3010032115 | Apollo Renal Therapeutics, LLC | 1 | N | 2026-01-01 | 2811 NE 14th St Ocala FL US 34470 |
| 3017877290 | 3017877290 | APOLLO BIOTECH CO., LTD. | 1 | N | 2026-01-01 | 18F-1 No. 75 Xintai 5th Road Xizhi 22101 New Taipei City TW 22101 |
| 3042941930 | 3042941930 | APOLLO LENS MANUFACTURING PHILIPPINES, INC. | 1 | N | 2026-01-01 | Lot 32 Ph 1, Cavite Technopark-Sez, Sabang Naic Cavite PH 4100 |
| 2182947 | 2182947 | APOLLO CORP. | 1 | N | 2020-04-25 | 450 MAIN ST. SOMERSET WI US 54025 |
| 3005252437 | 3005252437 | Apollo Enterprise Imaging Corp | 1 | N | 2020-04-25 | 8245 Boone Blvd. Suite 620 Tysons VA US 22182 |
| 3006722112 | 3006722112 | APOLLO ENDOSURGERY INC | 1 | Y | 2020-04-25 | 1120 S Capital of TX Hwy Bldg 1, Ste 300 Austin TX US 78746 |
| 3014678701 | 3014678701 | APOLLO MED INNOVATIONS | 1 | N | 2020-04-25 | 401 Highway 74 North Peachtree City GA US 30269 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 107964 | 1012338125 | P140012 | RESHAPE INTEGRATED DUAL BALLOON SYSTEM | LTI | 2015-07-28 |
| 107964 | 1893474275 | P140008 | ORBERA INTRAGASTRIC BALLOON | LTI | 2015-08-05 |
| 69095 | 1612168090 | K802335 | WHIRLPOOL BATHING UNIT-#2001 | ILJ | 1980-10-10 |
| 107964 | 1916779720 | K191439 | OverStitch 2-0 Polypropylene Suture | OCW | 2019-08-29 |
| 107964 | 1551884497 | K181141 | OverStitch Endoscopic Suturing System and Accessories | OCW | 2018-06-27 |
| 107964 | 2059802659 | K171886 | OverStitch SX Endoscopic Suturing System (ESS) | OCW | 2017-11-15 |
| 107964 | 1367002273 | K122270 | OVERTUBE ENDOSCOPIC ACCESS SYSTEM | FED | 2012-09-28 |
| 107964 | 1905668621 | K103155 | SUMO ACCESS AND TISSUE RESECTION SYSTEM | ODC | 2011-10-28 |
| 107964 | 1013053395 | K090583 | ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165 | KGE | 2009-06-26 |
| 107964 | 1358138834 | K082114 | ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00 | KNS | 2008-12-19 |
| 107964 | 1574428040 | K082102 | GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 | FED | 2010-06-14 |
| 107964 | 1118649435 | K081853 | OVERSTITCH ENDOSCOPIC SUTURE SYSTEM | OCW | 2008-08-18 |
| 175953 | 1006332822 | ||||
| 175953 | 1369856446 | ||||
| 107964 | 1372255758 | ||||
| 225089 | 1785034982 | ||||
| 95695 | 1866546834 | ||||
| 175953 | 1141591020 | ||||
| 346964 | 1362888380 | ||||
| 175953 | 1430177666 | ||||
| 175953 | 1453965152 | ||||
| 306088 | 1566618109 | ||||
| 175953 | 1571270840 | ||||
| 346964 | 1748070329 | ||||
| 346964 | 1766803301 | ||||
| 175953 | 1882249062 | ||||
| 293903 | 1886566502 | ||||
| 175953 | 1930715852 |
Product Codes Associated With Registrations#
NDC#
HDX
Ethyl Alcohol
Antibacterial LHS
Benzalkonium Chloride
DD Mart Hand Sanitizer
Alcohol
Hand Sanitizer
Alcohol
Hand Sanitizer
Alcohol
Hand Sanitizer
Alcohol
Discount Drug Mart
Benzalkonium Chloride
CVS
Petrolatum
Mens Sport
PYRITHIONE ZINC
CVS Gold
Selenium Sulfide
Gold LHS
Benzalkonium Chloride
Pyrithione Zinc
CVS
CVS ANTI DANDRUFF
Pyrithione Zinc
CVS Itchy Scalp
Pyrithione Zinc
Hy-Vee LHS
Benzalkonium Chloride
Hyvee LHS
Benzalkonium Chloride
White Tea
Benzalkonium Chloride
Hyvee LHS
Bwenzalkonium Chloride
Hyvee Foaming LHS-Pear
Benzalkonium Chloride
Hyvee LHS
Benzalkonium Chloride
berkley jensen
BENZALKONIUM CHLORIDE
berkley jensen
BENZALKONIUM CHLORIDE
HIMark
Benzalkonium Chloride
HiGHMARK
Alcohol
HIMARK
Alcohol
Everyday Clean
Pyrithione Zinc
Giant Eagle
Alcohol
Life is Simple Hand Sanitizer
Non-Alcohol Foaming Hand Sanitizer
Guard
Alcohol
Natural Concepts Hand Sanitizer
Ethyl Alcohol
Classic Clean
Shampoo
Hand Sanitizer
ALCOHOL
Moxie
Ethyl Alcohol
Autumn Bliss Hand Sanitizer
Ethyl Alcohol
Sweet Cinnamon Hand Sanitizer
Ethyl Alcohol
Winter Frost Hand Sanitizer
Ethyl Alcohol
PMA#
ORBERA ® Intragastric Balloon (IGB) System
APOLLO ENDOSURGERY INC1120 S Capital Of Tx Hwybldg 1, Ste 300austin, TX 78746-0000 PMA NumberP140008 Supplement NumberS024 Date Received07/11/2022 Decision Date10/05/2022 Product Code LTI Advisory Committee Gastroenterology/Urology Supplement Typereal-time...
ORBERA® Intragastric Balloon (IGB) System
APOLLO ENDOSURGERY INC
ORBERA Intragastric Balloon (IGB) System
APOLLO ENDOSURGERY INC
ORBERA Intragastric Balloon System
APOLLO ENDOSURGERY INC
ORBERA Intragastric Balloon System
APOLLO ENDOSURGERY INC
ORBERA Intragastric Balloon System
APOLLO ENDOSURGERY INC
Orbera Intragastric Balloon
APOLLO ENDOSURGERY INC
ORBERA Intragastric Balloon System
APOLLO ENDOSURGERY INC
ORBERA Intragastric Balloon
APOLLO ENDOSURGERY INC
Orbera Intragastric Balloon System
APOLLO ENDOSURGERY INC
Orbera Intragastric Balloon System
APOLLO ENDOSURGERY INC
Orbera Intragastric Balloon
APOLLO ENDOSURGERY INC
Orbera Intragastric Balloon System
APOLLO ENDOSURGERY INC
ORBERA Intragastric Balloon System
APOLLO ENDOSURGERY INC
ORBERA INTRAGASTRIC BALLOON SYSTEM
APOLLO ENDOSURGERY INC
ORBERA INTRAGASTRIC BALLOON SYSTEM
APOLLO ENDOSURGERY INC
ORBERA INTRAGASTRIC BALLOON SYSTEM
APOLLO ENDOSURGERY INC
ORBERA INTRAGASTRIC BALLOON
APOLLO ENDOSURGERY INC
PMN#
Apollo ESG NXT System, Apollo REVISE NXT System
Apollo Endosurgery, Inc.
OverStitch NXT Endoscopic Suturing System
Apollo Endosurgery, Inc.
OverStitch Sx Endoscopic Suturing System
Apollo Endosurgery, Inc.
Foley Balloon Catheter For Urology
Apollon Co., Ltd.
X-Tack Endoscopic HeliX Tacking System
Apollo Endosurgery, Inc.
ApolloVue S100 Image System
Apollo Medical Optics, Ltd.
AutoMIStar
Apollo Medical Imaging Technology Pty. Ltd.
OverStitch 2-0 Polypropylene Suture
Apollo Endosurgery
OverStitch Endoscopic Suturing System And Accessories
Apollo Endosurgery
OverStitch SX Endoscopic Suturing System (ESS)
Apollo Endosurgery Inc
VENUS FACET SCREW SYSTEM
APOLLO SPINE, INC.
OVERTUBE ENDOSCOPIC ACCESS SYSTEM
APOLLO ENDOSURGERY, INC.
ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL
APOLLO SPINE
SUMO ACCESS AND TISSUE RESECTION SYSTEM
APOLLO ENDOSURGERY, INC.
ZENITH PEDICLE SYSTEM
APOLLO SPINE, INC.
ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR
APOLLO SPINE, INC.
ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL
APOLLO SPINE, INC.
GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00
APOLLO ENDOSURGERY, INC.
COMET ANTERIOR CERVICAL PLATE SYSTEM
Apollo Spine, Inc.
ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165
APOLLO ENDOSURGERY, INC.
APOLLO ANTERIOR CERVICAL PLATE SYSTEM
Apollo Spine, Inc.
ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00
APOLLO ENDOSURGERY, INC.
OVERSTITCH ENDOSCOPIC SUTURE SYSTEM
APOLLO ENDOSURGERY, INC.
APOLLO IR HEAT LAMP SYSTEM
APOLLO PHYSICAL THERAPY PRODUCTS INTERNATIONAL
MISTAR, MODEL V3.2
APOLLO MEDICAL IMAGING TECHNOLOGY PTY LTD.
REMEDY MODEL 2Z12
APOLLO CORP.
SENTRY SCALE
APOLLO ENTERPRISE, LTD. CO.
APOLLO MOBILE SCALE
APOLLO ENTERPRISE, LTD. CO.
APOLLO VS, VT, VR 1000/1500, FREEDOM HS, HT, HR
APOLLO DENTAL PRODUCTS, INC.
APOLLO CONDOM
APOLLO ENTERPRISE, LTD. CO.
PHASE V-MODEL 1500 RUVA
APOLLO'S SUNTANNING SUPPLIES
FREEDOM LINE LUBRICATED MODELS LS-2-5, LT-6-10
APOLLO DENTAL PRODUCTS, INC.
APOLLO AIR FLUIDIZED BED
APOLLO FLUID DYNAMICS
APOLLO HEART RATE INDICATOR
APOLLO PRODUCTS, INC.
Applications#
GUDID#
DIRECTscan™ Adapter Universal Kit Replacement Screw - DS-UniScrew
2026-03-04
DIRECTscan™ Adapter Kit - Complete - DS-Kit
2026-03-04
DIRECTscan™ Adapter Double Wing-H - DS2000-09H
2026-03-04
DIRECTscan™ Adapter Double Wing-G - DS2000-09G
2026-03-04
DIRECTscan™ Adapter Double Wing-F - DS2000-09F
2026-03-04
DIRECTscan™ Adapter Double Wing-E - DS2000-09E
2026-03-04
DIRECTscan™ Adapter Single Wing-D - DS1000-09D
2026-03-04
DIRECTscan™ Adapter Single Wing-C - DS1000-09C
2026-03-04
DIRECTscan™ Adapter Single Wing-B - DS1000-09B
2026-03-04
Apollo Corp - Advantage Whirlpool Spa Bathing System
2025-11-17
Apollo Corp. - Essence Air Spa bathing system.
2016-08-01
Apollo Corp. - Essence Whirlpool bathing system.
2016-08-01
Apollo Corp - Solares Bathing System
2020-06-05
OverStitch NXT Endoscopic Suturing System - Needle Driver and Anchor Exchange
2024-10-01
ORBERA Intragastric Balloon System - Intragastric Balloon
2015-08-24
Apollo Revise NXT System - Single Channel Endobariatric System
2023-11-16
Apollo ESG NXT System - Single Channel Endobariatric System
2023-11-16
NXT Tissue Helix Pro - Tissue Helix
2023-11-16
OverStitch NXT Endoscopic Suturing System - Needle Driver and Anchor Exchange
2023-11-16
NXT Tissue Helix Pro - Tissue Helix
2023-11-16
X-Tack Endoscopic HeliX Tacking System - X-Tack Endoscopic HeliX Tacking System (235 cm)
2021-07-12
X-Tack Endoscopic HeliX Tacking System - X-Tack Endoscopic HeliX Tacking System (160 cm)
2021-07-12
OverStitch Endoscopic Suturing System - Apollo 2-0 Polypropylene Suture to be utilized with the OverStitch Endoscopic Suturing System
2019-10-31
OverStitch Endoscopic Suturing System - Tissue Helix
2016-10-07
OverStitch Endoscopic Suturing System - Suture Cinch
2016-08-19
OverStitch Endoscopic Suturing System - Needle Driver and Anchor Exchange
2016-08-19
OverStitch Endoscopic Suturing System Sx - Needle Driver and Anchor Exchange
2021-05-26
OverTube Endoscopic Access System - OverTube (Non-Sterile)
2016-08-17
OverTube Endoscopic Access System - OverTube (Sterile)
2016-08-17
Apollo 2-0 Polypropylene Endobariatric Suture - Apollo 2-0 Polypropylene Suture to be utilized with the Apollo ESG Dual and Single Channel Endobariatric suture system and the Apollo Revise Dual and Single Channel Endobariatric suture system
2023-01-10
APOLLO REVISE™ Sx System - Single Channel Endobariatric System
2023-01-10
APOLLO Revise™ System - Dual Channel Endobariatric System
2023-01-10
APOLLO ESG Sx™ System - Single Channel Endobariatric System
2023-01-10
APOLLO ESG™ System - Dual Channel Endobariatric System
2023-01-10
Apollo 2-0 Polypropylene Endobariatric Suture - Apollo 2-0 Polypropylene Suture to be utilized with the Apollo ESG Dual and Single Channel Endobariatric suture system and the Apollo Revise Dual and Single Channel Endobariatric suture system
2023-01-10
X-Tack Endoscopic HeliX Tacking System - Suture Cinch - Long
2021-07-12
LAP-BAND - LAP-BAND System Calibration Tube
2016-08-12
Gastric Balloon Suction Catheter - Bio Gastric Balloon Suction Catheter
2014-08-26
LAP-BAND Calibration Tube - PACKAGED LAP-BAND CAL TUBE (US)
2014-08-26
LAP-BAND - LAP-BAND System Tubing Kit
2016-08-12