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.

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

Filters: Cleared only ×
175,820 results
148777–148800 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 29, 1985
BACTIGEN GROUP B STREPTOCOCCUS TEST
K850772 · GTZ
Armkel, LLC
Microbiology · 93d
Cleared May 29, 1985
TYPE FP30 DIGITAL HEARING AID ANALYZER
K850918 · ETW
Frye Electronics, Inc.
Ear, Nose, Throat · 85d
Cleared May 29, 1985
ACA PROTHROMBIN TIME ANALYTICAL TEST PACK
K851125 · GJS
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 71d
Cleared May 29, 1985
ACA ACTIVATED PARTIAL THROMBOPLASTIN TIME ANALYTIC
K851126 · GGW
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 71d
Cleared May 29, 1985
DUPONT ACA PROTHROMBIN TIME/ACTIVATED PARTIAL THRO
K851127 · JPA
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 71d
Cleared May 29, 1985
CHAMBER V-9 PLUS AGAR
K851238 · JSJ
Bug City Company, Inc.
Microbiology · 63d
Cleared May 29, 1985
LERE NAIL & PLATE COMBIN. ONE PIECE FORGED
K851349 · KTW
Medicalex
Orthopedic · 55d
Cleared May 29, 1985
SEPTOSIL SILICONE FOR PRECISION IMPRESSION
K851388 · ELW
Specialites Septodont
Dental · 50d
Cleared May 29, 1985
STERILE GENERAL HOSPITAL SUPPLIES
K851390 · LDQ
Biological & Environmental Control...
General & Plastic Surgery · 50d
Cleared May 29, 1985
EARETTE HEARING AID(BEHIND THE EAR OTICON E35F
K851429 · ESD
Oticon Corp.
Ear, Nose, Throat · 49d