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
165889–165912 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 10, 1980
DIOSCAN
K802341 · IYO
Sonometrics Systems, Inc.
Radiology · 75d
Cleared Dec 10, 1980
LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT
K802661 · CDZ
Damon Corp.
Chemistry · 43d
Cleared Dec 10, 1980
TRANSCUTANEOUS ELECTRIC NERVE STIMULATOR
K802678 · GZJ
General Medical Industries, Inc.
Neurology · 42d
Cleared Dec 10, 1980
LANCER URIC ACID AUTO/STAT KIT
K802692 · KNK
Sherwood Medical Co.
Chemistry · 41d
Cleared Dec 10, 1980
OREIA-Q-TY, ENZYME IMMUNOASSAY
K802693 · KLI
Organon, Inc.
Chemistry · 41d
Cleared Dec 10, 1980
NEONATAL PHOTOTHERAPY UNIT
K802702 · LBI
Ohio Medical Products
General Hospital · 37d
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