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
165049–165072 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 10, 1980
AMES SERA-PAK URIC ACID REAGENT KIT
K802724 · KNK
Miles Laboratories, Inc.
Hematology · 40d
Cleared Dec 10, 1980
FLUFF UNDERPAD TYPE UP1002
K802730 · KME
Bio D Corp.
General Hospital · 37d
Cleared Dec 10, 1980
FLUFF UNDERPAD TYPE UP1001
K802740 · KME
Bio D Corp.
General Hospital · 37d
Cleared Dec 10, 1980
CENTRIFICHEM COMB. SERUM-BASED CALIB.
K802741 · JIX
Union Carbide Corp.
Chemistry · 37d
Cleared Dec 10, 1980
AMES SERA-PAK CHOLESTEROL REAGENT KIT
K802743 · CHH
Miles Laboratories, Inc.
Chemistry · 37d
Cleared Dec 10, 1980
POROUS, BREATHING TAPE W/RELEASE LINER
K802752 · KGX
Bioadhesive Systems, Inc.
General & Plastic Surgery · 37d
Cleared Dec 10, 1980
LOAD SENTINEL II, TRANS. ELEC. NERVE
K802779 · GZJ
Powers Medical Systmes
Neurology · 36d
Cleared Dec 10, 1980
JACKSON HYDRO SYSTEM
K802780 · FNG
S. Jackson, Inc.
General Hospital · 35d
Cleared Dec 10, 1980
BEDDING PADS EGGCREATE PADS
K802781 · IKY
Leemart Bedding Mfg. Co.
General Hospital · 35d
Cleared Dec 10, 1980
ELASTIC OPEN WEAVE BANDAGE
K802784 · FQM
Secol Co.
General Hospital · 36d
Cleared Dec 10, 1980
TUBULAR BANDAGE
K802789 · FQM
Secol Co.
General Hospital · 36d
Cleared Dec 10, 1980
CELLONA
K802792 · ITG
Secol Co.
Physical Medicine · 36d
Cleared Dec 10, 1980
ORTHOPEDIC PADDING
K802795 · KGX
Secol Co.
General & Plastic Surgery · 36d
Cleared Dec 10, 1980
HEXOKINASE, GLUCOSE
K802810 · CFR
Beckman Instruments, Inc.
Chemistry · 33d
Cleared Dec 10, 1980
ORTHOFIX AXIALEXTERNAL FIXATION SYS.
K802814 · JEC
Cintor Orthopaedic Div.
Orthopedic · 33d
Cleared Dec 10, 1980
TRAVENOL 24 HR. INFUSOR (ELASTOMERIC PP)
K802820 · FRN
Travenol Laboratories, S.A.
General Hospital · 30d
Cleared Dec 10, 1980
MILLAR MIKRO-TIP CATHETER PHONOTRANS
K802830 · DXW
Millar Instruments, Inc.
Cardiovascular · 30d
Cleared Dec 10, 1980
TETRA NATAL-MAT WATER FLOTATION MAT.
K802833 · IKY
Tetra Group U.S.A., Inc.
General Hospital · 28d
Cleared Dec 10, 1980
DR. MICHAEL'S FOOT HELPER
K802837 · LDQ
Dr. Michael'S Foot-Care Products
General & Plastic Surgery · 28d
Cleared Dec 09, 1980
BIOLOGICAL INDICATOR - KEMMED & BIOSURE
K802228 · FRC
Kem Medical Products Corp.
General Hospital · 90d
Cleared Dec 09, 1980
CHEMICAL INDICATOR - KEM MED & BIO SURE
K802229 · JOJ
Kem Medical Products Corp.
General Hospital · 90d
Cleared Dec 05, 1980
BIOLUMIN. SCREENING FOR BACT. BY ATP A.
K803077
Technology, Inc.
Chemistry
Cleared Dec 02, 1980
GENERATOR, HIGH VOLT, X-RAY, DIAG. MPX80
K802548 · IZO
General Electric Co.
Radiology · 48d
Cleared Dec 02, 1980
GENERATOR, HIGH VOLT, X-RAY, MPX 100
K802549 · IZO
General Electric Co.
Radiology · 48d