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
155137–155160 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 1984
C4 ANTIGEN ANTIBODY CONTROL
K834605 · DBI
Technicon Instruments Corp.
Immunology · 116d
Cleared Jan 23, 1984
K-FLEX OSTOMY POUCH
K840266
Coloplast A/S
Gastroenterology & Urology
Cleared Jan 20, 1984
RESPITRACE 300SC
K823780 · BZK
Respitrace Corp.
Anesthesiology · 401d
Cleared Jan 20, 1984
CHLORIDE REAGENT SET
K832438 · CHJ
Amresco, Inc.
Chemistry · 179d
Cleared Jan 20, 1984
ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS
K834140 · KTL
Intl. Diagnostic Technology
Immunology · 51d
Cleared Jan 19, 1984
DECUBITUS CARE ABSORBENT DRESSING
K832407 · FRO
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 182d
Cleared Jan 18, 1984
ECG INTERFERENCE FILTER TF-03
K832888 · DPS
La Jolla Technology, Inc.
Cardiovascular · 145d
Cleared Jan 18, 1984
ORTHO B-HCG SLIDE TEST FOR PREGNANCY
K833137 · JHJ
Ortho Diagnostic Systems, Inc.
Chemistry · 126d
Cleared Jan 18, 1984
TANDEM R-TOTAL B-GCG KIT
K833194 · JHI
Hybritech, Inc.
Chemistry · 121d
Cleared Jan 18, 1984
YASARGIL STANDARD ANEURYSM CLIP &
K833650 · HCH
Advanced Biosearch Assn.
Neurology · 91d
Cleared Jan 18, 1984
ACID BASE LABORATORY ABL4
K833696 · CEM
Radiometer America, Inc.
Chemistry · 92d
Cleared Jan 18, 1984
AUTO AIC ANALYZER SYSTEM
K833772 · LCP
Helena Laboratories
Chemistry · 83d
Cleared Jan 18, 1984
DURAZYME CPK
K833781 · CGS
American Monitor Corp.
Chemistry · 82d
Cleared Jan 18, 1984
T4 RIA
K833850 · CDX
Syncor Intl. Corp.
Chemistry · 75d
Cleared Jan 18, 1984
RESCUE MASK
K834250 · BTM
Rondex Products, Inc.
Anesthesiology · 42d
Cleared Jan 18, 1984
PAEDIATRIC FACE MASK 1-3 W/WO RING
K834454 · BSJ
Warne Surgical Products, Ltd.
Anesthesiology · 30d
Cleared Jan 17, 1984
CREATININE REAGENT SET
K832439 · CGX
Amresco, Inc.
Chemistry · 176d
Cleared Jan 17, 1984
AIRWAY MASKS
K832512 · CAE
Artec Environmental Monitoring Division
Anesthesiology · 174d
Cleared Jan 17, 1984
UNSCENTED MENSTRUAL TAMPON
K832818 · HEB
Bnt Co, Inc.
Obstetrics & Gynecology · 151d
Cleared Jan 17, 1984
BREAST THERMAL ACTIVITY INDICATOR
K832989 · KYA
Bcsi Laboratories, Inc.
Radiology · 138d
Cleared Jan 17, 1984
KODAK EKTACHEM 700 ANALYZER
K833833 · JJE
Eastman Kodak Company
Chemistry · 75d
Cleared Jan 17, 1984
RIA COAT DIGOXIN
K833842 · DPO
Immuno Assay Corp.
Toxicology · 75d
Cleared Jan 17, 1984
OP-CON SURGICAL INSTRUMENT #9
K834169 · BWB
Imm Enterprises , Ltd.
Anesthesiology · 57d
Cleared Jan 17, 1984
STAYFREE* DEODORANT MAXI-PADS
K834302 · HHL
Johnson & Johnson Professionals, Inc.
Obstetrics & Gynecology · 39d