Company ยท US
Allergan, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 2021. Name variants (Inc, Corp, punctuation) are merged.
39510(k) clearances (0 in 12 months)
26recalls (0 in 12 months)
10recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LPN | Accessories, Soft Lens Products | 13 |
| FTR | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled | 12 |
| LCJ | Tissue Expander And Accessories | 9 |
| HPX | Lens, Contact (Polymethylmethacrylate) | 8 |
| HQC | Unit, Phacofragmentation | 3 |
| MRD | Mammary Sizer | 3 |
| FWM | Prosthesis, Breast, Inflatable, Internal, Saline | 2 |
| HNO | Keratome, Ac-Powered | 2 |
| KYF | Implant, Eye Valve | 2 |
| LTI | Implant, Intragastric For Morbid Obesity | 2 |
| QBR | Intranasal Electrostimulation Device For Dry Eye Symptoms | 2 |
| EIB | Syringe, Irrigating (Dental) | 1 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 1 |
| GWL | Amplifier, Physiological Signal | 1 |
| HNR | Forceps, Ophthalmic | 1 |
| KYB | Lens, Guide, Intraocular | 1 |
| KYG | Device, Irrigation, Ocular Surgery | 1 |
| OXF | Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 2, 2021 | K203229 | NATRELLE INSPIRA Single Use Sizers for Gel Implants Allergan | MRD |
| Aug 31, 2020 | K193589 | TrueTear Intranasal Tear Neurostimulator Allergan | QBR |
| Aug 8, 2019 | K190674 | REFRESH RELIEVA For CONTACTS Allergan, Inc. | LPN |
| Dec 21, 2018 | K180826 | Natrelle 133 Plus MICROCELL Tissue Expander Allergan | LCJ |
| Aug 29, 2018 | K182054 | Natrelle 133S Tissue Expander Allergan | LCJ |
| May 17, 2018 | DEN170086 | TrueTear Intranasal Tear Neurostimulator Allergan | QBR |
| Nov 21, 2016 | K161457 | XEN Glaucoma Treatment System Allergan, Inc. | KYF |
| Aug 20, 2015 | K143354 | Natrelle 133 Plus Tissue Expander Allergan, Inc. | LCJ |
| Apr 25, 2013 | K123128 | SERI SURGICAL SCAFFOLD Allergan | OXF |
| Jul 9, 2009 | K083812 | REFRESH OPTIVE LENS COMFORT REWETTING DROPS Allergan, Inc. | LPN |
| Sep 14, 2005 | K051852 | SINGLE AMPLIFIER FOR BOTOX Allergan, Inc. | GWL |
| Feb 20, 2002 | K014202 | COMPLETE BRAND MULTI-PURPOSE SOLUTION Allergan, Inc. | LPN |
| Feb 11, 2002 | K013479 | COMPLETE BRAND MULTI-PURPOSE SOLUTION Allergan, Inc. | LPN |
| Feb 21, 2001 | K003252 | COMPLETE BRAND MULTI-PURPOSE SOLUTION Allergan, Inc. | LPN |
| Feb 13, 2001 | K003638 | MOJAVE CATARACT EXTRACTION SYSTEM Allergan, Inc. | HQC |
| Nov 21, 2000 | K003109 | COMPLETE BRAND LUBRICATING AND REWETTING DROPS Allergan, Inc. | LPN |
| Jun 2, 2000 | K000164 | COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION Allergan, Inc. | LPN |
| Oct 7, 1999 | K992028 | REFRESH CONTACTS LUBRICATING AND REWETTING DROPS Allergan, Inc. | LPN |
| Dec 18, 1998 | K984383 | ULTRACARE NEUTRALIZING TABLETS Allergan, Inc. | LPN |
| Nov 25, 1998 | K983150 | COMPLETE BRAND LUBRICATING AND REWETTING DROPS Allergan, Inc. | LPN |
| Sep 1, 1998 | K981168 | COMPLETE BRAND MULTI-PURPOSE SOLUTION, COMPLETE BRAND LUBRICATING AND REWETTING DROPS Allergan, Inc. | LPN |
| Jul 6, 1998 | K980775 | COMPLETE BRAND MULTI-PURPOSE SOLUTION Allergan, Inc. | LPN |
| May 19, 1998 | K981116 | SOVEREIGN CATARACT EXTRACTION SYSTEM Allergan, Inc. | KYG |
| Jun 13, 1997 | K971186 | AMO DIPLOMAX/OPSYS CONSOLE Allergan, Inc. | HQC |
| Sep 19, 1996 | K962402 | AMO PRESTIGE DAY PACK (ALLERGAN, INC.) Allergan, Inc. | HQC |
| Jun 17, 1996 | K961242 | AMO PHACOFLEX II INTERSECTION SYSTEM Allergan, Inc. | KYB |
| Jan 14, 1988 | K874543 | MODEL OPO-32 IRRIGATION SLEEVE Allergan, Inc. | EIB |
| May 29, 1987 | K870807 | BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE Allergan, Inc. | HNO |
| Dec 15, 1986 | K864065 | BKS-42 DISPOSABLE VACUUM TUBING PACK Allergan, Inc. | HNO |
| Oct 31, 1986 | K864003 | PACO-FOLDER (TM) INTRAOCULAR LENS FORCEPS Allergan, Inc. | HNR |
| Aug 29, 1986 | K863201 | NEW USE FOR ACUVAC SUCTION RESERVOIR 400CC Allergan, Inc. | GCY |
| Jun 2, 1986 | K861643 | STYLEKEEPER CONTACT LENS CARRYING CASE Allergan, Inc. | HPX |
| May 29, 1986 | K861642 | LENSKEEPER CONTACT LENS CARRYING CASE Allergan, Inc. | HPX |
| Oct 22, 1982 | K822706 | PRE-SERT Allergan, Inc. | HPX |
| Oct 18, 1982 | K822707 | CLEAN-N-SOAK Allergan, Inc. | HPX |
| May 13, 1982 | K821054 | TOTAL Allergan, Inc. | HPX |
| May 13, 1982 | K821052 | SOAKARE Allergan, Inc. | HPX |
| May 13, 1982 | K821051 | LIQUIFILM WETTING SOLUTION Allergan, Inc. | HPX |
| May 10, 1982 | K821055 | BLINK-N-CLEAN Allergan, Inc. | HPX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 29, 2020 | Allergan PLC REFRESH CONTACTS Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile Terminated |
LPN | K992028 |
| Nov 6, 2019 | Allergan PLC NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive gel), Inspira F (responsive gel), Inspira LP (responsive gel), Inspira M (responsive gel), Inspira L Terminated |
MRD | K831566 |
| Nov 6, 2019 | Allergan PLC Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 7627 SCLP, 7628 SCM, 76 Terminated |
FTR | None listed |
| Nov 6, 2019 | Allergan PLC Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45
Style 10/UDI:
NATRELLE Style 10-180 Gel Round Mod 10888628001206,
NATRELL Terminated |
FTR | None listed |
| Nov 6, 2019 | Allergan PLC Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP,
Style LP/UDI:
NATRELLE Style 68LP-125 Saline Round Low 10888628000513,
NATRELLE Style 6 Terminated |
FWM | None listed |
| Oct 30, 2019 | Allergan PLC XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatment. Open, Classified |
KYF | K161457 |
| Sep 11, 2019 | Allergan PLC Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles 150 FH and 150 SH.
Product Usage: Breast augmentation and Breast reconstruction Open, Classified |
FTR | None listed |
| Sep 11, 2019 | Allergan PLC RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML, RMM, RFL, RFM
Product Usage: Breast augmentation and Breast reconstruction Open, Classified |
FTR | None listed |
| Sep 11, 2019 | Allergan PLC Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM
Product Usage: Breast augmentation and Breast reconstruction Open, Classified |
FTR | None listed |
| Sep 11, 2019 | Allergan PLC Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), BIOCELL, Styles 110 Soft Touch and 120 Soft Touch
Product Usage : Breast augmentation and Breast reconstruction Open, Classified |
FTR | None listed |
| Sep 11, 2019 | Allergan PLC Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX
Product Usage: Breast augmentation and Breast reconstruction Open, Classified |
FTR | None listed |
| Sep 11, 2019 | Allergan PLC Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM, LF, ML, MM, MF, FL, FM, FF
Product Usage: Breast augmentation and Breast reconstruction Open, Classified |
FTR | None listed |
| Sep 11, 2019 | Allergan PLC McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153
Product Usage: Breast augmentation and Breast reconstruction Open, Classified |
FTR | None listed |
| Sep 11, 2019 | Allergan PLC McGhan Croissant-Shaped Tissue Expanders, Style 134
Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection unti Open, Classified |
LCJ | K862203 |
| Sep 11, 2019 | Allergan PLC Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G Needle Infusion Set
STYLE 133FV-T:
133FV-11-T,
133FV-12-T,
133FV-13-T,
133FV-14-T,
133 Open, Classified |
LCJ | K102806 K862203 |
| Sep 11, 2019 | Allergan PLC Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion Set, Sterile, for the following style numbers:
STYLE 133 Open, Classified |
LCJ | K143354 |
| Sep 11, 2019 | Allergan PLC Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site Tissue Expander) BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion S Open, Classified |
LCJ | K102806 K862203 |
| Sep 11, 2019 | Allergan PLC Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers:
Style 110:110-090,
110-120,
110-150,
110-180,
110-210,
110-240,
110-270,
11 Open, Classified |
FTR | None listed |
| Sep 11, 2019 | Allergan PLC Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers:
Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL-230,TRL-260,TRL-290,TRL-320,TRL-350,TRL-380,TRL-410, Open, Classified |
FTR | None listed |
| Sep 11, 2019 | Allergan PLC Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Biocell Low Height Low Projection, Sterile, for the following style numbers:
Syle LL: LL-410135,LL-410180,LL-410210,LL Open, Classified |
FTR | None listed |
| Sep 11, 2019 | Allergan PLC Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers:
Style 163:163-360CC, 163-440CC, 163-530CC, 163-655CC, 163-780CC;
Style 168:168-1 Open, Classified |
FWM | None listed |
| Jul 18, 2015 | Allergan Inc Natrelle CUI Series Tissue Expanders.
Product Usage:
Natrelle CUI Series Tissue Expander has been designed for temporary implantation to develop a skin flap. The device is used for reconstructive cor Terminated |
LCJ | K865056 |
| Jul 18, 2015 | Allergan Inc Natrelle 133 Series Tissue Expanders
Product Usage:
Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile sa Terminated |
LCJ | K862203 |
| Jul 7, 2015 | Allergan Inc Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410.
The product is packaged in a thermoformed tray (double sterile barrier) and enclosed in a labeled carton. Terminated |
MRD | K831566 |
| May 2, 2011 | Allergan Lap-Band Access Port Needle 10-Pack, 20 G x 51 mm (2 in.), Product Code: 8-20302-10, Lot Number: 9L01N
20 gauge, 51 mm (2 in.) length non-coring deflected tip (Huber) needle, used with the LAP-BAND Sy Terminated |
LTI | None listed |
| Nov 18, 2010 | Allergan LAP-BAND Adjustable Gastric Band System; Product codes:
B-2105 (ACCSS PRT II KIT (0-10CC) US),
B-2106 (ACCESS PRT II KIT (0-14CC) US),
B-2210 (LP-BND SYS, 9.75, STER, US),
B-2215 (LAP-BAND 9.75 W/ACC Terminated |
LTI | None listed |