Atlas FDA

LZU

49 FDA 510(k) clearances · Product code

89 daysmedian time to decision
223 days90th percentile
49clearances measured

FDA profile

Official device name
Plug, Punctum
Device class
Unclassified
Medical specialty
Unknown
Adverse events (MAUDE)
2009: 11 · 2010: 5 · 2011: 6 · 2012: 7 · 2013: 17 · 2014: 10
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Hello,eyes® BIO Plug (K241229)Bio Optics Co., Ltd.2024-06-28
Visant Medical Canalicular Plug (K222164)Visant Medical, Inc.2022-12-23
SOFT PLUG Extended Duration 180 Tapered Canalicular Plug (K213988)Oasis Medical, Inc.2022-06-03
Tear Pool Dissolvable Punctum Plugs (K190210)Alphamed, Inc.2019-10-24
Soft Plug Extended Duration 180 Canalicular Plug (K162361)Oasis Medical, Inc.2017-04-17
LacriPro Punctum Plug (K161673)Lacrimedics, Inc.2016-11-18
PDO Absorbable Punctum Plug (K150288)Riverpoint Medical2015-08-28
VERAPLUG (K140352)Krishna Imports Inc Dba Stephens Instruments2014-11-13
COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG, (K140711)Paragon Bioteck, Inc.2014-06-20
COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST (K140026)Lacrimedics, Inc.2014-06-03
FLOW CONTROLLER (K090938)Odyssey Medical, Inc.2009-06-04
SNUG PLUG PUNCTUM PLUG (K061398)Fci Ophthalmics, Inc.2006-07-11
EAGLEVISION GELLANSERTS, MODEL REF 0040 (K053333)Eagle Vision, Inc.2006-05-02
DELTA PUNCTUM PLUG (K050851)Delta Life Science, Inc.2005-08-19
HYDROGEL CANALICULAR PLUG (K040912)Partners IN Biomaterials, Inc.2004-11-16
INTELIPORT OCCLUDING DEVICE (K040231)Alcon, Inc.2004-07-13
OPAQUE HERRICK LACRIMAL PLUG (K030300)Lacrimedics, Inc.2003-05-09
SMART PLUG, MODEL 500; SMARTPLUG FORCEPS, MODEL 502; PUSH ROD, MODEL 503 (K022043)Medennium, Inc.2002-10-18
MOIST PUNCTAL PLUG SYSTEM (K021936)Moist Medical, Inc.2002-10-16
SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG (K020882)Surgical Specialties Corp2002-07-26
OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB (K021831)Lacrimedics, Inc.2002-07-01
SOFT PLUG ABSORBABLE PLUG-SA (K013613)Oasis Medical, Inc.2002-06-27
OCCU-FLO PUNCTUM PLUGS (K001768)U.S. Iol, Inc.2000-09-19
BIOINSULATED SILICONE PUNCTUM PLUG (K001234)Advanced Vision Science2000-07-11
OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM (K001737)Lacrimedics, Inc.2000-06-19
FLEXPLUG (K991130)Eagle Vision, Inc.1999-04-20
SURGIDEV SILICONE PUNCTUM PLUG (K980844)Advanced Vision Science1998-05-11
SILICONE PUNCTAL PLUG (K980437)Oasis Medical, Inc.1998-04-30
PUNCTUAL OCCLUDER (K972523)Odyssey Medical, Inc.1997-09-09
PUNCTUAL OCCLUDER (K970631)Odyssey Medical, Inc.1997-04-23
HERRICK ULTIMATE PUNCTUM PLUG (K963708)Lacrimedics, Inc.1997-04-14
HERRICK ULTIMATE PUNCTUM PLUG (K963501)Lacrimedics, Inc.1997-04-14
PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS (K964774)Fci Ophthalmics, Inc.1996-12-20
READY-SET PUNCTAL PLUGS (K961909)Fci Ophthalmics, Inc.1996-07-25
VISITEC COLLAR BUTTON CATHETER {GRIFFITHS} (K953394)Visitec Co.1995-10-12
OPHTA SIL- PUNCTAL PLUGS (MODIFICATION) (K954094)G.W.B. Intl., Ltd.1995-10-05
OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)} (K950569)G.W.B. Intl., Ltd.1995-03-14
COLLAGEN INTRACANALICULAR PLUG (K946357)Oasis Medical, Inc.1995-02-07
SILICONE PUNCTAL PLUG (K945906)Oasis Medical, Inc.1995-01-03
VISITEC CANALICULAR STENT (K915809)Visitec Co.1992-02-24
EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG (K905427)Eagle Vision, Inc.1991-06-06
OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS (K911108)G.W.B. Intl., Ltd.1991-05-13
LACRIMAL PLUG (K905750)Tamcenan Corp.1991-03-14
LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT (K897190)Look, Inc.1990-03-28
HERRICK LACRIMAL PLUG TM. (K896175)Lacrimedics, Inc.1990-01-22
COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST (K895342)Lacrimedics, Inc.1989-11-02
LACRIMAL EFFICIENCY TEST (TM) (K890714)Lacrimedics, Inc.1989-05-17
TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT (K890919)Eagle Vision, Inc.1989-05-16
EAGLE VISION-FREEMAN(TM) PUNCTAL VALVE (K890920)Eagle Vision, Inc.1989-04-11

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Every clearance here is in the API, with alerts when new ones post.