Allergan, Inc.
Allergan, Inc. holds FDA 510(k) medical device clearances, first cleared 1982, most recent 2019, with 3 FDA device recalls on record.
Top product codes for Allergan, Inc.
FDA recalls by Allergan, Inc.
- Z-2104-2015 — 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 correction of a defect or to provide cover for a prosthetic implant. The CUI Tissue Expander consists of a silicone elastomer envelope and a remote injection port.
- Z-2103-2015 — 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 saline for injection until the desired amount of tissue is developed.
- Z-1988-2015 — 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Allergan, Inc.
- K190674 — REFRESH RELIEVA For CONTACTS
- K161457 — XEN Glaucoma Treatment System
- K143354 — Natrelle 133 Plus Tissue Expander
- K083812 — REFRESH OPTIVE LENS COMFORT REWETTING DROPS
- K051852 — SINGLE AMPLIFIER FOR BOTOX
- K014202 — COMPLETE BRAND MULTI-PURPOSE SOLUTION
- K013479 — COMPLETE BRAND MULTI-PURPOSE SOLUTION
- K003252 — COMPLETE BRAND MULTI-PURPOSE SOLUTION
- K003638 — MOJAVE CATARACT EXTRACTION SYSTEM
- K003109 — COMPLETE BRAND LUBRICATING AND REWETTING DROPS
- K000164 — COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION
- K992028 — REFRESH CONTACTS LUBRICATING AND REWETTING DROPS
- K984383 — ULTRACARE NEUTRALIZING TABLETS
- K983150 — COMPLETE BRAND LUBRICATING AND REWETTING DROPS
- K981168 — COMPLETE BRAND MULTI-PURPOSE SOLUTION, COMPLETE BRAND LUBRICATING AND REWETTING DROPS
- K980775 — COMPLETE BRAND MULTI-PURPOSE SOLUTION
- K981116 — SOVEREIGN CATARACT EXTRACTION SYSTEM
- K971186 — AMO DIPLOMAX/OPSYS CONSOLE
- K962402 — AMO PRESTIGE DAY PACK (ALLERGAN, INC.)
- K961242 — AMO PHACOFLEX II INTERSECTION SYSTEM
- K874543 — MODEL OPO-32 IRRIGATION SLEEVE
- K870807 — BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE
- K864065 — BKS-42 DISPOSABLE VACUUM TUBING PACK
- K864003 — PACO-FOLDER (TM) INTRAOCULAR LENS FORCEPS
- K863201 — NEW USE FOR ACUVAC SUCTION RESERVOIR 400CC
- K861643 — STYLEKEEPER CONTACT LENS CARRYING CASE
- K861642 — LENSKEEPER CONTACT LENS CARRYING CASE
- K822706 — PRE-SERT
- K822707 — CLEAN-N-SOAK
- K821051 — LIQUIFILM WETTING SOLUTION
- K821052 — SOAKARE
- K821054 — TOTAL
- K821055 — BLINK-N-CLEAN
Data sourced from openFDA. This site is unofficial and independent of the FDA.