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

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175,820 results
149473–149496 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 09, 1985
RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 RE
K850365 · DSF
Eaton Medical Group
Cardiovascular · 69d
Cleared Apr 09, 1985
MODEL 78231D CARDIAC OUTPUT MODULE
K850568 · DXG
Hewlett-Packard Co.
Cardiovascular · 56d
Cleared Apr 09, 1985
IMED 440 INFUSION PUMP & ADMINISTRATION SET
K850653 · FRN
Imed Corp.
General Hospital · 49d
Cleared Apr 09, 1985
PROMINJECT PROGRAMMABLE INFUSION PUMP
K850669 · FRN
Pharmacia, Inc.
General Hospital · 48d
Cleared Apr 09, 1985
CORMED II AMBULATORY INFUSION PUMP
K850674 · FRN
Cormed, Inc., Sub. C.R.Bard, Inc.
General Hospital · 48d
Cleared Apr 09, 1985
ACUFLO VOLUMETRIC CONTROLLED DELIVERY SYS 2000
K850729 · FRN
Surgidev Corp.
General Hospital · 46d
Cleared Apr 09, 1985
AEF POSIDYNE I.V. FILTER/AIR ELIMINATOR
K850825 · FPB
Pall Biomedical Products Co.
General Hospital · 40d
Cleared Apr 09, 1985
POSIDYNE SOLUTION CONTAINER FILTER, RECORDER #96
K850826 · FPB
Pall Biomedical Products Co.
General Hospital · 40d
Cleared Apr 09, 1985
EQUIPMENT SNAP KOVERS
K850959 · JAA
Advance Medical Designs, Inc.
Radiology · 32d
Cleared Apr 09, 1985
URETERAL DILATION SET
K851144 · EZN
Van-Tec, Inc.
Gastroenterology & Urology · 19d
Cleared Apr 09, 1985
GAMBRO PRESSURE MONITOR GUARDS
K851230 · FIB
Gambro, Inc.
Gastroenterology & Urology · 14d
Cleared Apr 08, 1985
BIOMEDICS BLADDER SCANNER
K842687 · ITX
Biomedics
Radiology · 272d
Cleared Apr 08, 1985
MISCELLANEOUS GENERAL SURGICAL CUSTOM KIT
K844597
Xanmed Corp.
General & Plastic Surgery · 133d
Cleared Apr 08, 1985
KORVIN VITA RADIOPAQUE PLASTIC TEETH
K844670 · ELM
Credent Co.
Dental · 129d
Cleared Apr 08, 1985
ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN
K844765 · EWQ
Laser Spectrum, Inc.
Ear, Nose, Throat · 122d
Cleared Apr 08, 1985
POST-AURICULAR HEARING AID MODEL PE 600PPCH
K844862 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 115d
Cleared Apr 08, 1985
SYS STIM 206(MODEL-ME 206) MUSCLE STIMULATOR
K850013 · IPF
Mettler Electronics Corp.
Physical Medicine · 96d
Cleared Apr 08, 1985
BACI 6 -ADRENOCORTICOTROOP HORMONE
K850053 · CKG
Euro-Diagnostics BV
Chemistry · 90d
Cleared Apr 08, 1985
LUNE AU CURETTES
K850068 · HCY
Luneau Laboratories
Obstetrics & Gynecology · 90d
Cleared Apr 08, 1985
CONFIRM IMMUNOASSAY FOR DETECTTION STREP-PYOGENES
K850256 · GTZ
Abbott Laboratories
Microbiology · 76d
Cleared Apr 08, 1985
MICROSURGERY VISIBILITY BACKGROUND MATERIAL
K850375
Ethicon, Inc.
General & Plastic Surgery · 67d
Cleared Apr 08, 1985
ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEM
K850509 · LNK
Laser Media
Gastroenterology & Urology · 59d
Cleared Apr 08, 1985
PRECO PREGNANCY RAPID CARD TEST, HEM #2028
K850604 · JHJ
Preco, Inc.
Chemistry · 52d
Cleared Apr 08, 1985
MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE
K850728 · LNK
Cooper Lasersonics, Inc.
Gastroenterology & Urology · 45d