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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
119737–119760 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 23, 1991
LOW POROSITY (LP) VASCULAR PROSTHESIS
K912911 · DSY
Intervascular, Inc.
Cardiovascular · 83d
Cleared Sep 23, 1991
STARPAC O.R. TOWEL
K912947 · KKX
Multi M Intl., Inc.
General Hospital · 80d
Cleared Sep 23, 1991
FLEXIFLO OVER THE GUIDEWIRE JEJUNAL FEEDING TUBE
K912972 · FPD
Abbott Laboratories
Gastroenterology & Urology · 77d
Cleared Sep 23, 1991
BACTIDROP(TM) FERRIC CHLORIDE (10%)
K913002 · JTO
Remel Co.
Microbiology · 77d
Cleared Sep 23, 1991
BACTIDROP(TM) VOGES-PROSKAUER A
K913003 · JTO
Remel Co.
Microbiology · 77d
Cleared Sep 23, 1991
BACTIDROP(TM) DOBELL & O'CONNOR IODINE
K913006 · JTO
Remel Co.
Microbiology · 77d
Cleared Sep 23, 1991
BACTIDROP(TM) VOGES-PROSKAUER B
K913007 · JTO
Remel Co.
Microbiology · 77d
Cleared Sep 23, 1991
BACTIDROP(TM) OXIDASE
K913008 · JTO
Remel Co.
Microbiology · 77d
Cleared Sep 23, 1991
DIGITAL FLUORO STORE(DFS) W/NUMERICAL SUFFIXES
K913012 · JAA
Eigen
Radiology · 77d
Cleared Sep 23, 1991
HEMATASTAT C-70B
K913128 · GKG
Separation Technology, Inc.
Hematology · 136d
Cleared Sep 23, 1991
BODEN WHEELCHAIR DRAINAGE SYSTEM
K913142 · KNX
Mno Medical Products
Gastroenterology & Urology · 69d
Cleared Sep 23, 1991
MODIFIED OSCOR PY PACING LEADS/MODIFICATION
K913158 · DTB
Oscor Medical Corp.
Cardiovascular · 77d
Cleared Sep 23, 1991
INNOFLUOR(TM) DIGITOXIN REAGENT SET
K913187 · LFM
Intl. Bioclinical, Inc.
Toxicology · 67d
Cleared Sep 23, 1991
PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION
K913201 · DTB
Oscor Medical Corp.
Cardiovascular · 77d
Cleared Sep 23, 1991
IMPLANT PACING LEAD, TINED #3262, MODIFICATION
K913202 · DTB
Oscor Medical Corp.
Cardiovascular · 77d
Cleared Sep 23, 1991
IMPLANT PACING LEAD TINED #3390, MODIFICATION
K913203 · DTB
Oscor Medical Corp.
Cardiovascular · 77d
Cleared Sep 23, 1991
MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION
K913204 · DTB
Oscor Medical Corp.
Cardiovascular · 77d
Cleared Sep 23, 1991
OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF
K913205 · DTB
Oscor Medical Corp.
Cardiovascular · 77d
Cleared Sep 23, 1991
SURGIFIT STERILE SURGICAL GLOVES
K913215 · KGO
Hevealactics Intl. Sdn Bhd
General Hospital · 66d
Cleared Sep 23, 1991
VPW2906A1: 480V, 3 PHASE, X-RAY POWER SUPPLY
K913234 · IZO
Varian Canada, Inc.
Radiology · 63d
Cleared Sep 23, 1991
ALWAYS, SCENTED/SCENTED DEODORIZED MENSTRUAL PAD
K913237 · HHL
Procter & Gamble Co.
Obstetrics & Gynecology · 63d
Cleared Sep 23, 1991
ALWAYS, UNSCENTED MENSTRUAL PAD
K913238 · HHL
Procter & Gamble Co.
Obstetrics & Gynecology · 63d
Cleared Sep 23, 1991
LATEX EXAMINATION GLOVES
K913279 · LYY
Liwe Trading
General Hospital · 62d
Cleared Sep 23, 1991
ETUDE (MODEL NUMBERS 24A05 & 24A06)
K913323 · FAP
Dantec Medical, Inc.
Gastroenterology & Urology · 60d