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
146305–146328 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 1985
ABSORBANCE (ABS) TEST PAK
K854784 · JIT
Diagnostic Systems
Chemistry · 20d
Cleared Dec 19, 1985
EPIDURAL ANESTHESIA NEEDLES
K854816 · BSP
Reganes, Inc.
Anesthesiology · 16d
Cleared Dec 19, 1985
BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY
K854919 · DXY
Cook Pacemaker Corp.
Cardiovascular · 10d
Cleared Dec 18, 1985
DEN-MAT PAINT-ON RUBBER DAM
K852630 · EIE
Den-Mat Corp.
Dental · 181d
Cleared Dec 18, 1985
FIBRELIGHT NASAL SPECULA
K853588 · EPY
Downs Surgical , Ltd.
General & Plastic Surgery · 113d
Cleared Dec 18, 1985
BRONCHIAL CYTOLOGY BRUSH
K853667
E-Z-Em, Inc.
Cardiovascular · 106d
Cleared Dec 18, 1985
5.0 MHZ INTRACAVITARY SECTOR PROBE
K853711 · HEM
General Electric Co.
Obstetrics & Gynecology · 104d
Cleared Dec 18, 1985
MODEL 310 IMPEDANCE SYSTEM
K853863 · ETY
Virtual Corp.
Ear, Nose, Throat · 92d
Cleared Dec 18, 1985
MA25 PORTABLE AUDIOMETER
K853919 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 86d
Cleared Dec 18, 1985
INT'L MODEL XG BEHIND-THE-EAR HEARING AID
K853941 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 85d
Cleared Dec 18, 1985
INT'L MODEL XE BEHIND-THE-EAR HEARING AID
K853942 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 85d
Cleared Dec 18, 1985
INFUSAID INFUSE-A-PORT (MODIFIED)
K853981 · LJT
Intermedics/Infusaid, Inc.
General Hospital · 82d
Cleared Dec 17, 1985
PVL-4.8-200 BALLOON STONE EXTRACTOR
K851954 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 228d
Cleared Dec 17, 1985
ZIMMON BILIARY STENT SET
K851962 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 228d
Cleared Dec 17, 1985
OVUTIME OVULATION PREDICTOR TEST
K853142 · CEP
Advanced Care Products
Chemistry · 141d
Cleared Dec 17, 1985
MODIFIED MYDRIATIC SPECTACLE
K854140
La Rue Optical
Ophthalmic · 68d
Cleared Dec 17, 1985
BATTLE CREEK DIGI-TRACKER ELCTRIC TREADMILL
K854148 · IOL
Battle Creek Equipment Co.
Physical Medicine · 67d
Cleared Dec 17, 1985
TIP OFF FORCEPS
K854541 · GEN
Keller Instruments, Inc.
General & Plastic Surgery · 34d
Cleared Dec 17, 1985
HYPODERMIC NEEDLE AND STYLET
K854579 · GAA
Berkley and Co.
General & Plastic Surgery · 32d
Cleared Dec 17, 1985
MALIS MICRO BIPOLAR COAGULATOR
K854592 · GEI
Valley Forge Scientific Corp.
General & Plastic Surgery · 29d
Cleared Dec 17, 1985
SURGICAL BLADES
K854620 · GES
Niraj Industries
General & Plastic Surgery · 29d
Cleared Dec 17, 1985
X-RAY DETECTABLE COTTON BALLS
K854714 · GDY
American Silk Sutures, Inc.
General & Plastic Surgery · 25d
Cleared Dec 17, 1985
SURGICAL INSTRUMENT TRAY
K854746 · FSM
Zbi, Inc.
General & Plastic Surgery · 21d
Cleared Dec 17, 1985
THE CALIFORNIA SPLINT
K854752 · DXQ
Intl. Medication Systems, Ltd.
Cardiovascular · 21d