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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
158857–158880 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 07, 1983
COBAS STANDARD FOR TOTAL PROTEIN
K823576 · LER
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS REAGENT FOR CALCIUM
K823577 · CIC
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS STANDARDS FOR CALCIUM-IN-ORGANIC
K823578 · CIO
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS REAGENT FOR TOTAL PROTEIN
K823579 · CEK
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS REAGENT FOR INORGANIC PHOSPHORUS
K823580 · CEO
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
NML 6000 CT
K823679 · JQP
Nuclear Medical Laboratories, Inc.
Chemistry · 31d
Cleared Jan 07, 1983
BETA FFIRM TEST
K823682 · JHJ
Organon, Inc.
Chemistry · 31d
Cleared Jan 07, 1983
BIO INTERFERENCE BLANKING MATERIAL
K823687 · JJX
American Monitor Corp.
Chemistry · 31d
Cleared Jan 07, 1983
PHOSPHORUS REAGENT SET
K823691 · CEO
Omega Medical Electronics
Chemistry · 30d
Cleared Jan 07, 1983
SPINAL NEEDLE
K823692 · BSP
Ocean Medical Products, Ltd.
Anesthesiology · 30d
Cleared Jan 07, 1983
VASCU-STATT APPROXIMATOR
K823694 · HRQ
Scanlan Intl., Inc.
General & Plastic Surgery · 30d
Cleared Jan 07, 1983
EPIDURAL CATHETER
K823702 · BSO
Rsp, Inc.
Anesthesiology · 29d
Cleared Jan 07, 1983
ESOPHAGEAL STETHOSCOPE
K823703 · BZW
Rsp, Inc.
Anesthesiology · 29d
Cleared Jan 07, 1983
ATS GRAM STAIN CONTROL SLIDE
K823704 · LJG
Alpha-Tec Systems, Inc.
Hematology · 29d
Cleared Jan 07, 1983
ATS PARASITOLOGY STAIN CONTROL SLIDE
K823705 · LJG
Alpha-Tec Systems, Inc.
Hematology · 29d
Cleared Jan 07, 1983
ATS AFB STAIN CONTROL SLIDE
K823706 · LJG
Alpha-Tec Systems, Inc.
Hematology · 29d
Cleared Jan 07, 1983
TRIGLYCERIDE REAGENT (UV)
K823709 · CDT
Gilford Diagnostics
Chemistry · 29d
Cleared Jan 07, 1983
DISPOSABLE NON-REBREATHING ANES. CIRCUIT
K823714 · CAI
Marquest Medical Products, Inc.
Anesthesiology · 28d
Cleared Jan 07, 1983
SPECTROPHOTOMETER
K823720 · JJQ
Macomb Chemical Co.
Chemistry · 28d
Cleared Jan 07, 1983
GRAM NEGATIVE BACTERIAL IDENTIF- PANELS
K823738 · JTO
Micro-Media Systems, Inc.
Microbiology · 25d
Cleared Jan 07, 1983
ADVANCE EMIT-AED PRIMEDONE ASSAY
K823741 · LFT
Syva Co.
Chemistry · 25d
Cleared Jan 07, 1983
ADVANCE EMIT-AED ETHOSUXIMIDE
K823745 · DLF
Syva Co.
Chemistry · 25d
Cleared Jan 07, 1983
LOW PRESSURE BLOM-SINGER VOICE PROSTHES
K823749 · EWL
Bivona Medical Technologies
Ear, Nose, Throat · 25d
Cleared Jan 07, 1983
STERILE, DISPOS. SPIKE PROTECTOR-5C4138
K823777 · FKX
Travenol Laboratories, S.A.
Gastroenterology & Urology · 23d