FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
128449–128472 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 31, 1989
SYSTEMATE(TM) IRON ITEM NUMBER: 65417
K895249 · JIY
Em Diagnostic Systems, Inc.
Chemistry · 71d
Cleared Oct 31, 1989
SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402
K895250 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 71d
Cleared Oct 31, 1989
ULTRACISION ULTRASONIC SCALPEL
K895252 · GEI
Ultracision, Inc.
General & Plastic Surgery · 71d
Cleared Oct 31, 1989
HVA EIA KIT YAMASA
K895288 · CDF
Yamasa Shoy Co., Ltd.
Chemistry · 67d
Cleared Oct 31, 1989
LID LOC
K895364 · HOY
Spectrum Co.
Ophthalmic · 64d
Cleared Oct 31, 1989
CYBERFLUOR FIAGEN TSH
K895396 · JLW
Cyberfluor, Inc.
Toxicology · 60d
Cleared Oct 31, 1989
BIOPSY FORCEPS
K895415 · EOQ
Symbiosis Corp.
Ear, Nose, Throat · 56d
Cleared Oct 31, 1989
S.M.P.U. LATEX EXAMINATION GLOVES
K895438 · LYY
P.T. Surya Milani Plastic Utama
General Hospital · 56d
Cleared Oct 31, 1989
CANON AUTO REF-KERATOMETER RK-2
K895475 · HLQ
Canon USA, Inc.
Ophthalmic · 50d
Cleared Oct 31, 1989
BIO-RAD MODULAR AIR COMPRESSOR
K895575 · HKX
Bio-Rad
Ophthalmic · 47d
Cleared Oct 31, 1989
TUBING ORGANIZER
K895706 · KNT
3t Products, Inc.
Gastroenterology & Urology · 36d
Cleared Oct 31, 1989
IRMA-COUNT(TM) PAP, (RKPA1, RKPA2)
K895723 · JFH
Diagnostic Products Corp.
Chemistry · 36d
Cleared Oct 31, 1989
LEECO PREVIEW(R) EBV (EIA)
K895765 · KTN
Leeco Diagnostics, Inc.
Immunology · 35d
Cleared Oct 31, 1989
INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET
K895827 · LGR
Innotron of Oregon, Inc.
Toxicology · 29d