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
154057–154080 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 1984
CIN-SHEAR
K840352 · HFB
Roland J. Zwick, Inc.
Obstetrics & Gynecology · 70d
Cleared Apr 05, 1984
AIRWAY PRESSURE MONITOR
K840420 · CAP
Respiratory Support Products, Inc.
Anesthesiology · 65d
Cleared Apr 05, 1984
CYSTOTOME, 140-S
K840475 · HNY
Cilco, Inc.
Ophthalmic · 62d
Cleared Apr 05, 1984
ENGSTROM ELIZA DUO CO2 & O2 ANALYZ
K840645 · CCL
Gambro, Inc.
Anesthesiology · 50d
Cleared Apr 05, 1984
HARVARD ANTI-REFLUX Y-SET
K840760 · FPA
C.R. Bard, Inc.
General Hospital · 42d
Cleared Apr 05, 1984
DIRECT BILIRUBIN REAGENT
K840777 · CIG
American Dade
Chemistry · 57d
Cleared Apr 05, 1984
TRIGLYCERIDES REAGENT
K840780 · CDT
American Dade
Chemistry · 57d
Cleared Apr 05, 1984
PARAMAX UREA NITROGEN REAGENT
K840785 · CDQ
American Dade
Chemistry · 50d
Cleared Apr 05, 1984
BITESTICK BLOCK
K840789 · JXL
Cherry Plastics, Inc.
Neurology · 62d
Cleared Apr 05, 1984
TRNS MI 8202
K840821 · GZJ
Medical Scientific Instruments
Neurology · 41d
Cleared Apr 05, 1984
LEAP MONO TEST KIT
K840822 · KTN
Cooper Biomedical, Inc.
Immunology · 41d
Cleared Apr 05, 1984
THERACHEM TDC THERAPEUTIC DRUG CONTROL
K840921 · DIF
Fisher Diagnostics
Toxicology · 34d
Cleared Apr 05, 1984
MANUAL RESUSCITATION SYSTEM
K840935 · BTM
Inspiron Corp.
Anesthesiology · 31d
Cleared Apr 05, 1984
SOMAS HUMAN SPINAL FLUID CONTROL
K840974 · DFI
Somas Medical Industries, Inc.
Immunology · 30d
Cleared Apr 05, 1984
PREFILLED PULSATOR SYRINGE
K840986 · CBT
Concord Laboratories, Inc.
Anesthesiology · 29d
Cleared Apr 05, 1984
VAPORIZED HEPARIN
K840987 · CBT
Concord Laboratories, Inc.
Anesthesiology · 29d
Cleared Apr 05, 1984
PANCRETEC PUMP CHECK
K841018 · FRN
Pancretec, Inc.
General Hospital · 27d
Cleared Apr 05, 1984
PROVIDER CAP SET
K841028 · FPA
Pancretec, Inc.
General Hospital · 24d
Cleared Apr 05, 1984
RES-Q-MATE
K841120 · CAE
Rsq Industries, Inc.
Anesthesiology · 21d
Cleared Apr 05, 1984
LEVINE EOSIN METHYLENE BLUE AGAR
K841142 · JSI
Anaerobe Systems
Microbiology · 20d
Cleared Apr 05, 1984
PROPAGATING TRANSPORT
K841208 · JSN
Smith River Biologicals
Microbiology · 24d
Cleared Apr 05, 1984
SELECTIVE BROTH
K841211 · JSD
Smith River Biologicals
Microbiology · 24d
Cleared Apr 05, 1984
CYCLOSERINE-CEFOXITIN FRUCTOSE AGAR
K841218 · JSI
Anaerobe Systems
Microbiology · 14d
Cleared Apr 05, 1984
FILTER-FLEX
K841236 · CAH
Life Design Systems, Inc.
General Hospital · 14d