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
144769–144792 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 23, 1986
DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37
K860546 · KRG
Pacesetter Systems
Cardiovascular · 69d
Cleared Apr 23, 1986
MODEL E 600 ELECTROCARDIOGRAPH
K860767 · DSI
Kone Instruments, Inc.
Cardiovascular · 51d
Cleared Apr 23, 1986
VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE
K860771 · GCQ
Van-Tec, Inc.
Gastroenterology & Urology · 51d
Cleared Apr 23, 1986
GUIDED WIRE TORQUER
K860840 · DQX
Target Therapeutics
Cardiovascular · 50d
Cleared Apr 23, 1986
ANGIOJECT
K860842 · DXT
Target Therapeutics
Cardiovascular · 50d
Cleared Apr 23, 1986
CATHETER INTRODUCER
K860958 · DYB
Target Therapeutics
Cardiovascular · 41d
Cleared Apr 23, 1986
BIPOLAR CARDIAC PACEMAKER, MODEL 110
K861009 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 36d
Cleared Apr 23, 1986
LABOR-DELIVERY STRETCH/BED
K861030 · KNC
Adel Medical , Ltd.
Obstetrics & Gynecology · 36d
Cleared Apr 23, 1986
MODEL 2100 ND:YAG SURGICAL LASER PULMONARY INDICAT
K861045 · LLO
Sharplan Industries, Inc.
Anesthesiology · 36d
Cleared Apr 23, 1986
MODEL 366-10 ADAPTAID STEP-DOWN ADAPTER
K861110 · DTB
Intermedics, Inc.
Cardiovascular · 29d
Cleared Apr 23, 1986
ER-7C CLINICAL PROBE MICROPHONE
K861113 · ETW
Etymotic Research
Ear, Nose, Throat · 29d
Cleared Apr 23, 1986
DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES
K861153 · FMF
Exel Intl.
General Hospital · 28d
Cleared Apr 23, 1986
SHILEY SILICONE DUAL LUMEN SUBCLAVIAN CANNULA
K861174 · LFJ
Shiley, Inc.
Gastroenterology & Urology · 29d
Cleared Apr 23, 1986
GENTLE BACK, PLASTIC URINARY DRAINAGE BAG
K861192 · KNX
Advanced Clinical Products, Inc.
Gastroenterology & Urology · 23d
Cleared Apr 23, 1986
UROTOPO CATHETER
K861200 · KOD
Houston Biomedical, Inc.
Gastroenterology & Urology · 23d
Cleared Apr 23, 1986
MODEL ST HEARING AID
K861254 · ESD
Fine-Tune
Ear, Nose, Throat · 20d
Cleared Apr 23, 1986
FISCH DRILL IRRIGATOR
K861298 · KAR
Jedmed Instrument Co.
Ear, Nose, Throat · 16d
Cleared Apr 23, 1986
WHENEVER UNSCENTED REGULAR THIN MAXI-PADS
K861355 · HHD
Marcal Paper Mills, Inc.
Obstetrics & Gynecology · 13d
Cleared Apr 23, 1986
WHENEVER UNSCENTED SUPER THIN MAXI-PADS
K861356 · HHD
Marcal Paper Mills, Inc.
Obstetrics & Gynecology · 13d
Cleared Apr 23, 1986
WHENEVER UNSCENTED PANTY SHIELD
K861357 · HHD
Marcal Paper Mills, Inc.
Obstetrics & Gynecology · 13d
Cleared Apr 22, 1986
MODIFIED BRAIN ATLAS III
K854362 · GWE
Bio-Logic Systems Corp.
Neurology · 175d
Cleared Apr 22, 1986
GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR
K854499 · IZO
Gendex Corp.
Radiology · 161d
Cleared Apr 22, 1986
PHADEBAS RAST PHADEZYM RAST DISCS FX2,FX3 & FX5
K854865 · DHB
Pharmacia, Inc.
Immunology · 144d
Cleared Apr 22, 1986
DIAMED MODELS 600, 900, 960, 964
K854953 · JAA
Diamed Division Ill. Tool Works, Inc.
Radiology · 133d