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
162145–162168 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 1982
CORTISOL (RIA) KIT
K820074 · CGR
Immuno Assay Corp.
Chemistry · 16d
Cleared Jan 28, 1982
EMERSON THORACIC SUCTION REG. #55-JP
K820077 · KDP
J. H. Emerson Co.
General Hospital · 16d
Cleared Jan 28, 1982
POST-OP ELECTRODE (TENS ELECTRODE)
K820082 · GXY
Consolidated Medical Equipment, Inc.
Neurology · 16d
Cleared Jan 28, 1982
SUTTER CPM
K820083 · BXB
Sutter Biomedical, Inc.
Physical Medicine · 16d
Cleared Jan 28, 1982
CURITY SURGICAL SCRUB BRUSH SPONGE
K820086 · GEC
The Kendal Co.
General & Plastic Surgery · 16d
Cleared Jan 28, 1982
TSH (RIA) KIT
K820089 · JLW
Immuno Assay Corp.
Chemistry · 15d
Cleared Jan 28, 1982
ASTRA-T CALCIUM REAGENT
K820090 · CIC
Hi Chem, Inc.
Chemistry · 15d
Cleared Jan 28, 1982
PATHWAY PH BLOOD GAS CONTROL
K820103 · JJS
Beckman Instruments, Inc.
Chemistry · 13d
Cleared Jan 28, 1982
3M VOLUME VENTIATOR CIRCUIT
K820131 · BZO
3M Company
Anesthesiology · 10d
Cleared Jan 28, 1982
BABYBIRD 2 VENTILATOR
K820132 · CBK
3M Company
Anesthesiology · 10d
Cleared Jan 28, 1982
PRIMIDONE REAGENT TEST KIT
K820138 · DJD
Beckman Instruments, Inc.
Chemistry · 10d
Cleared Jan 28, 1982
PHILLY INFANT BOLT
K820151 · GWN
Philadelphia Medical Specialties
Neurology · 9d
Cleared Jan 26, 1982
IL 703, STAT SEPARATOR
K812750 · JRL
Instrumentation Laboratory CO
Hematology · 119d
Cleared Jan 26, 1982
MODERN MATERIALS' INLAY CSTG. WAXES,A-C
K812804 · EGD
Modern Materials
Dental · 112d
Cleared Jan 26, 1982
HEPAQUANT
K813011 · JOX
Streck Laboratories, Inc.
Pathology · 91d
Cleared Jan 26, 1982
TOXOELISA TEST KIT
K813221 · LGD
M.A. Bioproducts
Microbiology · 78d
Cleared Jan 26, 1982
CRITIKON TRANSCUTANEOUS GAS MONITORS
K813347 · KLK
Critikon Company, LLC
Anesthesiology · 60d
Cleared Jan 26, 1982
LINQUAL-ORAL TRAINING SPLINT
K813603
Charles F. Samelson, M.D.
Cardiovascular · 29d
Cleared Jan 26, 1982
SERALYZER CREATININE REAGENT STRIPS
K820075 · CGX
Miles Laboratories, Inc.
Chemistry · 14d
Cleared Jan 26, 1982
AFT SYSTEM PROFICIENCY TESTING PROGRAM
K820088 · DBL
Calbiochem-Behring Corp.
Immunology · 13d
Cleared Jan 25, 1982
IRRIGATION SYRINGE
K810185 · FQH
Karoco Intl.
General Hospital · 381d
Cleared Jan 25, 1982
TEGADERM TRANSPARENT DRESSING
K812678 · FRO
3M Company
General & Plastic Surgery · 125d
Cleared Jan 25, 1982
TRANSDUCER ANTISEPTIC TOWELETTE
K812776 · ITX
Echo Laboratories, Inc.
Radiology · 112d
Cleared Jan 25, 1982
SAGE 2200 STERILE SPECIMEN CONTAINER
K813408 · FMT
Sage Products, Inc.
Radiology · 49d