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
138265–138288 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 1987
ELECTROMEDICS D1079E
K873561 · DTR
Electromedics, Inc.
Cardiovascular · 64d
Cleared Nov 05, 1987
PEDIATRIC BUBBLE TRAP CAT. NO. B-100
K873610 · BSY
American Omni Medical, Inc.
Anesthesiology · 58d
Cleared Nov 05, 1987
CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE
K873894 · FPA
Travenol Laboratories, S.A.
General Hospital · 42d
Cleared Nov 05, 1987
AMERLITE TT4 ASSAY (240/480/144 TEST KITS)
K873976 · KLI
Amersham Corp.
Chemistry · 37d
Cleared Nov 05, 1987
EMDS PROCAINAMIDE CALIBRATOR ITEM NO. 67634/95
K874102 · DLJ
Em Diagnostic Systems, Inc.
Toxicology · 28d
Cleared Nov 05, 1987
MEDTRONIC MODEL 6550 ADJUSTABLE HEMOSTASIS VALVE
K874117 · DYG
Medtronic Vascular
Cardiovascular · 27d
Cleared Nov 05, 1987
TITAN GEL REP CPK-12 HV
K874146 · CGS
Helena Laboratories
Chemistry · 23d
Cleared Nov 04, 1987
THE EXPERT MODELS RTS 2000 AND RTS 2000H
K862947 · DSI
Ocg Technology, Inc.
Cardiovascular · 456d
Cleared Nov 04, 1987
HENKE-JECT PRESSURE SYRINGE (MODIFICATION)
K864294 · EGM
Smith & Nephew, Inc.
Dental · 369d
Cleared Nov 04, 1987
PREVENTETTE (CONDOM)
K872619 · HIS
Reb Enterprises, Inc.
Obstetrics & Gynecology · 121d
Cleared Nov 04, 1987
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
K872766 · DXY
Telectronics, Inc.
Cardiovascular · 113d
Cleared Nov 04, 1987
PACESTART
K872778 · DRO
Pacific Rim Engineering & Mfg.
Cardiovascular · 113d
Cleared Nov 04, 1987
PROLOG MP PULSE GENERATORS 658K AND 658T
K872779 · DXY
Pacesetter Systems
Cardiovascular · 113d
Cleared Nov 04, 1987
MODEL 78576A PAPER CHART RECORDER
K872822 · DSF
Hewlett-Packard Co.
Cardiovascular · 110d
Cleared Nov 04, 1987
EPICARIDA, LE
K872837 · DSI
Medicomp, Inc.
Cardiovascular · 107d
Cleared Nov 04, 1987
STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(597 ADHE)
K872869 · DXH
Labeltape Meditect, Inc.
Cardiovascular · 106d
Cleared Nov 04, 1987
AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT
K873064 · DHR
Amtec Diagnostics International, Inc.
Immunology · 91d
Cleared Nov 04, 1987
DYNABEADS HLA CELL PREP II ISOLATION PRODUCT
K873185 · JCF
Dynal Biotech, Inc.
Hematology · 84d
Cleared Nov 04, 1987
ECG BASED MEDIA
K873267 · KZI
Central Media
Microbiology · 85d
Cleared Nov 04, 1987
MUELLER HINTON MEDIA
K873268 · JTZ
Central Media
Microbiology · 85d
Cleared Nov 04, 1987
MYCOLOGICAL MEDIA
K873269 · JSI
Central Media
Microbiology · 85d
Cleared Nov 04, 1987
ACTINOMYCETE DIFFERENTIAL MEDIA
K873270 · JSH
Central Media
Microbiology · 85d
Cleared Nov 04, 1987
PROJECT 300 MICROASSAY BP-12, EIA MINILAB
K873451 · JJQ
Awareness Technology, Inc.
Chemistry · 69d
Cleared Nov 04, 1987
MEDIX BIOTECH FERRITIN ENZYME IMMUNOASSAY TEST KIT
K873730 · JMG
Medix Biotech, Inc.
Hematology · 50d