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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
146377–146400 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 10, 1985
MA-400 EMB FEEDBACK DEVICE
K853806 · HCC
Spectral Data Systems
Neurology · 90d
Cleared Dec 10, 1985
EASY EYES TM LENS CARRYING CASE
K853870 · HPX
Applied Laboratories, Inc.
Ophthalmic · 84d
Cleared Dec 10, 1985
QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT
K853930 · CEK
Quantimetrix Corp.
Chemistry · 77d
Cleared Dec 10, 1985
MODEL 210 INFUSION PUMP
K854073 · FRN
Avi, Inc.
General Hospital · 67d
Cleared Dec 10, 1985
MODEL 200 INFUSION PUMP
K854074 · FRN
Avi, Inc.
General Hospital · 67d
Cleared Dec 10, 1985
STERILE SALINE SOLUTION
K854155 · KMJ
I M, Inc.
General Hospital · 60d
Cleared Dec 10, 1985
PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES
K854232 · GEC
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 50d
Cleared Dec 10, 1985
CHURCHILL-HS SUSPENDED VENTED IV SET
K854627 · FPA
Churchill Corp.
General Hospital · 22d
Cleared Dec 10, 1985
CHURCHILL-H EXTENSION TUBE
K854629 · FPK
Churchill Corp.
General Hospital · 22d
Cleared Dec 10, 1985
CHURCHILL-HS SUSPENDED NON-VENTED IV SET
K854630 · FPA
Churchill Corp.
General Hospital · 22d
Cleared Dec 10, 1985
CHURCHILL-HE VENTED IV SET
K854636 · FPA
Churchill Corp.
General Hospital · 21d
Cleared Dec 10, 1985
MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC.
K854735 · IBJ
Portable Medical Laboratories, Inc.
Pathology · 15d
Cleared Dec 09, 1985
FLUID MANAGEMENT SYSTEM
K852645 · FRN
Haemonetics Corp.
General Hospital · 171d
Cleared Dec 09, 1985
MEDILOG M6
K852892 · DSI
Oxford Medilog, Inc.
Cardiovascular · 153d
Cleared Dec 09, 1985
PERIPHERAL NERVE STIMULATOR MODEL A400
K852962 · BXN
Fisher & Paykel Allied Products , Ltd.
Anesthesiology · 150d
Cleared Dec 09, 1985
CORON PRES MONITOR KIT MODEL 80 LEFT KIT MODEL 90
K853072 · DYB
Camino Laboratories, Inc.
Cardiovascular · 139d
Cleared Dec 09, 1985
RT3600(115V) RT3600(220/240V)
K853249 · ITX
General Electric Co.
Radiology · 130d
Cleared Dec 09, 1985
MODEL 804 (TENS)
K853442 · GZJ
Oriental Medical Supplies, Inc.
Neurology · 115d
Cleared Dec 09, 1985
MILLAR/GALANTE PRECOATED TOTAL KNEE
K853661 · JWH
Zimmer, Inc.
Orthopedic · 97d
Cleared Dec 09, 1985
ATRIUM PLASMA TFE SYNTHETIC ARTERY
K853725 · DSY
Atrium Medical Corp.
Cardiovascular · 94d
Cleared Dec 09, 1985
LIFEPAK 8 MODIFICATION
K853732 · DRO
Physio-Control Corp.
Cardiovascular · 94d
Cleared Dec 09, 1985
NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000
K853791 · DTR
Norton Performance Plastics Corp.
Cardiovascular · 89d
Cleared Dec 09, 1985
NEURO PULSE II
K853836 · GZJ
Nagata Engineering Co.
Neurology · 83d
Cleared Dec 09, 1985
LIFE WATCH RESPIRATORY MONITOR
K853840 · CHL
The Perkin-Elmer Corp.
Chemistry · 84d