FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
154297–154320 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 17, 1984
MED-OPEDIC SLEEP SYSTEM
K834344 · INX
Bemco Mattress Co.
Physical Medicine · 36d
Cleared Jan 17, 1984
NEW MOTHER'S WAY-BREAST PUMP
K834399 · HGY
Huntleigh Technology, Inc.
Obstetrics & Gynecology · 34d
Cleared Jan 17, 1984
TECHMEDICA-HEWSON SHOULDER CLEAT
K834411 · HTN
Techmedica, Inc.
Orthopedic · 33d
Cleared Jan 17, 1984
CAMPY BRUCELLA AGAR PLATE
K834417 · JSJ
Otisville Biotech, Inc.
Microbiology · 33d
Cleared Jan 17, 1984
CDC ANAEROBE BLOOD AGAR PLATE
K834418 · JSG
Otisville Biotech, Inc.
Microbiology · 33d
Cleared Jan 17, 1984
CTA MEDIUM TUBE
K834425 · JSG
Otisville Biotech, Inc.
Microbiology · 33d