FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
129025–129048 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 1989
DISPOSABLE LATEX EXAMINATION GLOVES
K891794 · LYY
Cn Asia Sdn Bhd
General Hospital · 222d
Cleared Oct 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892138 · LYY
Shanghai Latex Factory
General Hospital · 210d
Cleared Oct 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892163 · LYY
Canada Packers, Inc.
General Hospital · 207d
Cleared Oct 31, 1989
OSMOMETER STANDARD SOLUTIONS
K892329 · JIT
D.R.G. Scientific Industries
Chemistry · 209d
Cleared Oct 31, 1989
PATIENT EXAMINATION GLOVES
K892769 · LYY
Glw Intl. Corp.
General Hospital · 203d
Cleared Oct 31, 1989
PULSATILE PUMP FOR GONADORELIN ACETATE
K893488 · FRN
Ortho Pharmaceutical Corp.
General Hospital · 180d
Cleared Oct 31, 1989
CEDIA CORTISOL ASSAY
K893954 · JFT
Microgenics Corp.
Chemistry · 152d
Cleared Oct 31, 1989
DOUBLE ANTIBODY GLUCAGON
K893975 · JME
Diagnostic Products Corp.
Chemistry · 151d
Cleared Oct 31, 1989
EOS CHEMISTRY ANALYZER
K894035 · JGS
Eos Technology Corp.
Chemistry · 147d
Cleared Oct 31, 1989
ABBOTT TDX TOTAL T3 PLUS
K894238 · CDP
Abbott Laboratories
Chemistry · 132d
Cleared Oct 31, 1989
STERILE SURGEONS GLOVES
K894256 · KGO
Chung Shiang Rubber Industrial Co.
General Hospital · 133d
Cleared Oct 31, 1989
RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT
K894315 · KLE
Lee Pharmaceuticals
Dental · 109d
Cleared Oct 31, 1989
PATIENT EXAMINATION GLOVES
K894449 · LYY
Pascorp Newmarket Sdn. Bhd.
General Hospital · 141d
Cleared Oct 31, 1989
DIATHRON(R) DIATHERMY UNIT
K894513 · HJM
Intl. Ophthalmic Industries Corp.
Ophthalmic · 104d
Cleared Oct 31, 1989
'MED-TECH' LATEX EXAMINATION GLOVE
K894552 · LYY
Med-Tech Rubber & Engineering Industries
General Hospital · 103d
Cleared Oct 31, 1989
OLYMPUS PK-TP SYSTEM REACTIVE CONTROL
K894617 · GMI
Schiff & Co.
Microbiology · 103d
Cleared Oct 31, 1989
LP 400 MICROPLATE READER
K894859 · JJQ
Kallestad Diag, A Div. of Erbamont, Inc.
Chemistry · 92d
Cleared Oct 31, 1989
HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP.
K894918 · CCL
Mennen Medical, Inc.
Anesthesiology · 90d
Cleared Oct 31, 1989
MILENIA(TM) FSH (MKFS1,5)
K895005 · CGJ
Diagnostic Products Corp.
Chemistry · 84d
Cleared Oct 31, 1989
COBO TEMPORARY KERATOPROSTHESIS
K895013 · MLP
Ocular Instruments, Inc.
Ophthalmic · 84d
Cleared Oct 31, 1989
ACCI-GUARD REUSABLE HOLDER
K895075 · FMI
Medical Safety Products, Inc.
Chemistry · 78d
Cleared Oct 31, 1989
TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT
K895094 · CEP
Hybritech, Inc.
Chemistry · 78d
Cleared Oct 31, 1989
MODEL 590 OXYGEN CONCENTRATOR
K895141 · CAW
Puritan Bennett Corp.
Anesthesiology · 76d
Cleared Oct 31, 1989
MICROLASE BY LASER TRABECULOPLASTY
K895213 · HQF
Keeler Instruments, Inc.
Ophthalmic · 74d