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
155809–155832 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 1983
SERVOMED BASIC BEDSIDE UNIT SMV 104
K831783 · DXJ
Litton Medical Electronics
Cardiovascular · 167d
Cleared Nov 16, 1983
SERVOMED COMPACT MONITOR SMK 154-8/101
K832021 · DRT
Litton Medical Electronics
Cardiovascular · 146d
Cleared Nov 16, 1983
SERVOMED SMC 108/111-426-24, 111-426
K832022 · DXJ
Litton Medical Electronics
Cardiovascular · 146d
Cleared Nov 16, 1983
SERVOMED COMPACT MONITOR SMK 155-9
K832035 · DRT
Litton Medical Electronics
Cardiovascular · 146d
Cleared Nov 16, 1983
SERVOMED CENTRAL STATION SMV 206
K832131 · DRT
Litton Medical Electronics
Cardiovascular · 138d
Cleared Nov 15, 1983
ASAHI HOLLOW FIBER KIDNEYS, EXCEL
K833150 · KOC
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 61d
Cleared Nov 14, 1983
PERMALUX VISIBLE CURE COMPOSITE RESTOR
K831351 · EBF
Lares Manufacturing Co., Inc.
Dental · 203d
Cleared Nov 14, 1983
SINGLE BED ARRHYTHMIA MONITOR AM500
K831638 · DSI
Lifeline Systems, Inc.
Cardiovascular · 175d
Cleared Nov 14, 1983
ELECTRO-PULSE
K832160 · GZJ
Electro-Pulse
Neurology · 132d
Cleared Nov 14, 1983
PERIPHERAL TRANSLUMINAL ARGIOPLASTY
K832279
Sontek Corp.
General & Plastic Surgery · 125d
Cleared Nov 14, 1983
BP TRANSDUCER HOLDERS TH-2,3 & 4
K832384 · DXO
American Bentley
Cardiovascular · 118d
Cleared Nov 14, 1983
ENCODYNE 4 & VACUFIX 4
K832393
Elmed, Inc.
Neurology · 118d
Cleared Nov 14, 1983
TRANCOJECT DISPOSABLE SYRINGES
K832605 · FMF
Huborga, Inc.
General Hospital · 103d
Cleared Nov 14, 1983
BETA SCAN REAGENT STRIP
K832691 · CGA
Orange Medical Instruments, Inc.
Hematology · 96d
Cleared Nov 14, 1983
PNEU PAC VENTILATOR/RESUSCITATORS
K832700 · CBK
Pneupac , Ltd.
Anesthesiology · 96d
Cleared Nov 14, 1983
FOAM HELMET - USE W/ESOPHAGEAL TAMPONA
K832859 · KNT
Inmed Corp.
Gastroenterology & Urology · 83d
Cleared Nov 14, 1983
IMMUNOENZYME TEST SYS-DETECT-IGM ANTI
K832900 · GLZ
Bionetic Laboratory Products
Immunology · 77d
Cleared Nov 14, 1983
DEFAZOLIN 30MCG. SENSITIVITY DISCS
K832910 · JTN
Difco Laboratories, Inc.
Immunology · 77d
Cleared Nov 14, 1983
PRIMA-UNIPOLAR CARDIAC PULSE GENERAT
K832914 · DXY
Intermedics, Inc.
Cardiovascular · 77d
Cleared Nov 14, 1983
INIVOX ELECTRODE/CATHETER SYS
K832916 · LLE
Critikon Company, LLC
Neurology · 77d
Cleared Nov 14, 1983
PACEMAKER SYS. ANALYZER 378
K832959 · KRE
Siemens Elema AB
Cardiovascular · 76d
Cleared Nov 14, 1983
BACTERUERIA SCREENING PROCEDURE
K832975 · JXA
Turner Designs, Inc.
Microbiology · 74d
Cleared Nov 14, 1983
SOFFBAN ORTHOPEDIC PADDING
K832992 · ITG
Smith & Nephew, Inc.
Physical Medicine · 73d
Cleared Nov 14, 1983
PARAMAX BILIRUBIN CALIBRATORS
K833005 · JIX
American Dade
Chemistry · 94d