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
154993–155016 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 1984
RDW PARAMETER FOR THE TECHNICON H6000
K834026 · GKL
Technicon Instruments Corp.
Hematology · 69d
Cleared Jan 30, 1984
KINETIC ALKALINE PHOSPHATASE
K834033 · CJE
American Monitor Corp.
Chemistry · 68d
Cleared Jan 30, 1984
RIANEN FOLLICLE STIMULATING HORMONE
K834038 · CGJ
New England Nuclear
Chemistry · 68d
Cleared Jan 30, 1984
CARDIOTOMY RESERVOIR SC3500F
K834041 · DTP
Scimed Life Systems, Inc.
Cardiovascular · 68d
Cleared Jan 30, 1984
URIC ACID REAGENT SET
K834045 · KNK
Sterling Biochemical, Inc.
Chemistry · 68d
Cleared Jan 30, 1984
ENDAB T3
K834049 · CDP
Immunotech Corp.
Chemistry · 68d
Cleared Jan 30, 1984
INTRAVENOUS FILTER SET
K834130 · FPA
Tri-Med, Inc.
General Hospital · 77d
Cleared Jan 30, 1984
FLEXXR* CPM SYSTEM
K834203 · BXB
Qarex Laboratories, Inc.
Physical Medicine · 56d
Cleared Jan 30, 1984
PARALLEL FLAME PHOTOMETER & SODIUM
K834248 · JGT
American Monitor Corp.
Chemistry · 54d
Cleared Jan 30, 1984
CARDIODATA PACE RECORDER
K834257 · DSH
Cardio Data
Cardiovascular · 54d
Cleared Jan 30, 1984
LIQUI-URA TOXIC URINE CONTROL
K834259 · DIF
Biodiagnostic Intl
Toxicology · 54d
Cleared Jan 30, 1984
CONTINU-FLO SOLUTION ADMIN. 2C9102
K834289 · FPA
Travenol Laboratories, S.A.
General Hospital · 53d
Cleared Jan 30, 1984
MODULAR EXTREMITY CASTING SUPPORT
K834384 · LGG
Buckman Co., Inc.
Orthopedic · 47d
Cleared Jan 30, 1984
INFUSION PUMP PRIMER
K834461 · FRN
Parker Hannifin Corp.
General Hospital · 42d
Cleared Jan 30, 1984
TRAIL CHAIR
K834498 · IQC
Winchester Industries, Inc.
Physical Medicine · 41d
Cleared Jan 30, 1984
PACESAVER & SCOUT
K834506 · INI
Burke, Inc.
Physical Medicine · 40d
Cleared Jan 30, 1984
CALMTONE
K834519 · HCC
Thought Technology , Ltd.
Neurology · 40d
Cleared Jan 30, 1984
THROMBO PLUS
K834527 · GGK
W. Sarstedt, Inc.
Hematology · 40d
Cleared Jan 30, 1984
ELECTRODE LEAD CONSTRUCTION
K834533 · DTB
Telectronics, Inc.
Cardiovascular · 39d
Cleared Jan 30, 1984
PREMIER
K834552 · ITI
Everest & Jennings, Inc.
Physical Medicine · 34d
Cleared Jan 30, 1984
EGERTON TURNING & TILTING BED
K834563 · IKZ
Kinetic Concepts, Inc.
Physical Medicine · 33d
Cleared Jan 30, 1984
CLEAR LEADS-RADIOTRANSPARENT WIRES
K834583 · IKD
Quinton, Inc.
Physical Medicine · 32d
Cleared Jan 30, 1984
TRANSFERRIN, ANTIGEN, ANTIBODY, CONTROL
K834603
Technicon Instruments Corp.
Immunology · 122d
Cleared Jan 30, 1984
WHEELCHAIR MECHANICAL
K840024 · IOR
Amico Lab, Inc.
Physical Medicine · 25d