Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

97 results for "CooperVision, Inc."
25–48 of 97
Search insights Median review: 72d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Oct 26, 2004
COOPER PROSTHETIC
K042435 · LPL
CooperVision, Inc.
Ophthalmic · 48d
Cleared Jul 23, 2004
LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS
K041138 · LPL
CooperVision, Inc.
Ophthalmic · 84d
Cleared Nov 07, 2003
PROCLEAR COMPATIBLES MULTIFOCAL
K032873 · LPL
CooperVision, Inc.
Ophthalmic · 53d
Cleared Apr 26, 2002
FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR
K020392 · LPL
CooperVision, Inc.
Ophthalmic · 79d
Cleared Sep 13, 2000
METHAFILCON A
K002625 · LPL
CooperVision, Inc.
Ophthalmic · 21d
Cleared May 19, 2000
METHAFILCON A
K001090 · LPL
CooperVision, Inc.
Ophthalmic · 45d
Cleared May 19, 2000
POLYMACON
K001089 · LPL
CooperVision, Inc.
Ophthalmic · 45d
Cleared Mar 06, 2000
FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX
K000384 · LPL
CooperVision, Inc.
Ophthalmic · 28d
Cleared Nov 24, 1999
METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV...
K993252 · MVN
CooperVision, Inc.
Ophthalmic · 57d
Cleared Mar 15, 1999
TETRAFILCON A
K990606 · LPL
CooperVision, Inc.
Ophthalmic · 20d
Cleared May 13, 1998
PREFERENCE STANDARD, PREFERENCE TORIC, COOPER TORIC, COOPERCLEAR, COOPERHT,...
K980649 · LPL
CooperVision, Inc.
Ophthalmic · 83d
Cleared Dec 19, 1997
PREFERENCE 60 AND PREFERENCE 60 TORIC
K963013 · LPL
CooperVision, Inc.
Ophthalmic · 507d
Cleared Dec 17, 1996
HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT...
K962185 · LPL
CooperVision, Inc.
Ophthalmic · 194d
Cleared Nov 24, 1995
AQUASOFT (TETRAFILCON A) DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS
K954139 · LPL
CooperVision, Inc.
Ophthalmic · 84d
Cleared Jul 25, 1995
TETRAFILCON A HYDROPHILIC CONTACT LENSES
K950968 · LPL
CooperVision, Inc.
Ophthalmic · 146d
Cleared May 09, 1989
CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV.
K890635 · HQC
CooperVision, Inc.
Ophthalmic · 90d
Cleared Apr 17, 1989
INTERCASSETTE, INTERKIT, UNIVERSAL PAK & CASSETTE
K890300 · HQE
CooperVision, Inc.
Ophthalmic · 88d
Cleared Aug 02, 1988
RESUBMITTED DIODE LASER COAGULATOR
K882372 · HQF
CooperVision, Inc.
Ophthalmic · 68d
Cleared Apr 06, 1988
KOI(TM) INSTRUMENT TRAYS
K881095 · LRP
CooperVision, Inc.
General & Plastic Surgery · 22d
Cleared Apr 01, 1988
KOI(TM) BLADE GAUGE, MODEL KOI-132
K881094 · HOE
CooperVision, Inc.
Ophthalmic · 17d
Cleared Aug 17, 1987
COOPER SURG ASPIRATION CANNULA/CUSTOM CONVEN PAKS
K872214 · GEA
CooperVision, Inc.
General & Plastic Surgery · 69d
Cleared Jul 27, 1987
IN-LINE OPHTHALMIC IRRIGATING SOLUTION FILTERS
K871854 · HQC
CooperVision, Inc.
Ophthalmic · 75d
Cleared Jun 11, 1987
SERIES TEN THOUSAND OCUTOME
K871871 · HQE
CooperVision, Inc.
Ophthalmic · 29d
Cleared May 07, 1987
KRATZ NOVA-SERT
K871440 · KYB
CooperVision, Inc.
Ophthalmic · 24d