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
148177–148200 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 1985
ANESTHESIOMETER
K851557 · HJC
Luneau SA
Ophthalmic · 44d
Cleared May 30, 1985
MODEL 2000 INDULIN INFUSION PUMP
K851564 · FRN
Bd Becton Dickinson Vacutainer...
General Hospital · 44d
Cleared May 30, 1985
SOLEX & SAXON INT'L OPTICAL OF HONG KONG
K851661 · HQZ
South West Intl., Inc.
Ophthalmic · 37d
Cleared May 30, 1985
37-610 TO 37-880 VARIOUS OPHTHAL-FORCEPS
K851791 · HNR
Artiberia
Ophthalmic · 35d
Cleared May 30, 1985
37-940 TO 37-944 VARIOUS NOYES OPHTHALMIC FORCEPS
K851792 · HNR
Artiberia
Ophthalmic · 35d
Cleared May 30, 1985
ON TARGET
K851887 · HPX
Newman Assoc.
Ophthalmic · 29d
Cleared May 30, 1985
CRE BUFFER CRE DYE
K851993 · CGX
Alpkem Corp.
Chemistry · 23d
Cleared May 30, 1985
ALT (ALANINE AMINO-THRANSFERASE)REAGENT
K851995 · CKA
Alpkem Corp.
Chemistry · 23d
Cleared May 30, 1985
LD-P REAGENT
K851997 · CFJ
Alpkem Corp.
Chemistry · 23d
Cleared May 30, 1985
ALP(ALKALINE)(PHOSPHATASE) REAGENT
K851998 · CJE
Alpkem Corp.
Chemistry · 23d
Cleared May 30, 1985
CK-NAC REAGENT
K852000 · CGS
Alpkem Corp.
Chemistry · 23d
Cleared May 30, 1985
ALB BCG REAGENT
K852007 · CIX
Alpkem Corp.
Chemistry · 23d
Cleared May 30, 1985
T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL
K852008 · CIG
Alpkem Corp.
Chemistry · 23d
Cleared May 30, 1985
T-CHO REAGENT
K852009 · CHH
Alpkem Corp.
Chemistry · 23d
Cleared May 30, 1985
TGL REAGENT
K852010 · CDT
Alpkem Corp.
Chemistry · 23d
Cleared May 30, 1985
I.V. WATCH
K852029 · FPB
Alltek, Inc.
General Hospital · 22d
Cleared May 30, 1985
PEDIATRIC IV WATCH
K852030 · FPB
Alltek, Inc.
General Hospital · 22d
Cleared May 30, 1985
NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS)
K852140 · FPA
North American Instrument Corp.
General Hospital · 14d
Cleared May 29, 1985
BP-800
K843010 · DXN
Pollenex Associated Mills, Inc.
Cardiovascular · 301d
Cleared May 29, 1985
UP800 A UNIVERSAL PRINTER
K845050 · EWO
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 184d
Cleared May 29, 1985
HALIFAX SPINAL CLAMP
K850039 · KWP
Levtech, Inc.
Orthopedic · 142d
Cleared May 29, 1985
MARUKYR-BAN / HOT OR HEAT PACK
K850566 · IMD
Oriental Medical Supplies, Inc.
Physical Medicine · 106d
Cleared May 29, 1985
STROBEX ULTRON ELECTROSURGE-DENTAL UNIT
K850666 · EKZ
Ipco Corp.
Dental · 98d
Cleared May 29, 1985
VIGGO ACCESSORIES FOR I.V. THERAPY
K850769 · FPA
Viggo Products
General Hospital · 93d