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
146569–146592 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 1985
DELTA-LITE CASTING RESIN
K854341 · LGF
Johnson & Johnson Professionals, Inc.
Orthopedic · 25d
Cleared Nov 22, 1985
MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL
K854420 · GDM
Meadox Surgimed, Inc.
General & Plastic Surgery · 18d
Cleared Nov 22, 1985
FALKON STRETCH
K854432 · EFQ
G.B.F. Industries, Inc.
General & Plastic Surgery · 17d
Cleared Nov 22, 1985
MIDAS REX SURGICAL RUBBER DAM
K854462
Midas Rex Pneumatic Tools, Inc.
General & Plastic Surgery · 16d
Cleared Nov 21, 1985
THE NEW MCINTYRE CANNULA
K853777 · HMX
Microsurgical Technology, Inc.
Ophthalmic · 73d
Cleared Nov 21, 1985
CPAP BLOWER
K853944 · BTI
American Air & Process, Inc.
Anesthesiology · 58d
Cleared Nov 21, 1985
PLAYTEX LIGHT'N GENTLE UNSCENTED/DEODORANT/MINI TA
K854258 · HIL
Intl. Playtex, Inc.
Obstetrics & Gynecology · 30d
Cleared Nov 20, 1985
THERMO TRIM
K852637 · IRT
Suntec Health & Fitness Group, Inc.
Physical Medicine · 153d
Cleared Nov 20, 1985
ALPHA SUPER KART
K853766 · INI
Alpha Unlimited, Inc.
Physical Medicine · 72d
Cleared Nov 20, 1985
IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES
K854423 · LIB
Dynatech Laboratories, Inc.
Microbiology · 15d
Cleared Nov 20, 1985
BARD PARKER 150CC BELLOWS RESERVOIR
K854424 · GCY
Bd Becton Dickinson Vacutainer...
General & Plastic Surgery · 15d
Cleared Nov 19, 1985
GRECO-HARVEY SURFACTANT BONDED CATH FOR ANESTHESIO
K851244 · KDQ
Cook, Inc.
General Hospital · 266d
Cleared Nov 19, 1985
SCX-10 SINGLE CHANNEL RECORDER ACCESS. FOR G-2000
K851625 · DSF
Eaton Medical Group
Cardiovascular · 215d
Cleared Nov 19, 1985
SYS STIM 206 MODEL ME206
K851735 · GZJ
Mettler Electronics Corp.
Neurology · 208d
Cleared Nov 19, 1985
OMNIGRAPH 4000(ELECTROCARDIOGRAPH)
K852652 · DRS
Telemed Div.
Cardiovascular · 151d
Cleared Nov 19, 1985
CARDIORATER CR7
K852910 · DRT
Cardiac Recorders, Ltd.
Cardiovascular · 133d
Cleared Nov 19, 1985
LIGHT CURE FILLING MATERIAL
K853055 · EBF
Foremost Dental Mfg., Inc.
Dental · 123d
Cleared Nov 19, 1985
AXICARE CM-14 AUTOMATIC BREAST PUMP
K853107 · HGX
Crystal Medical Products, Inc.
Obstetrics & Gynecology · 119d
Cleared Nov 19, 1985
WATER DRIVEN BREAST PUMP BY BABY NURSE
K853326 · HGX
Baby Nurse
Obstetrics & Gynecology · 103d
Cleared Nov 19, 1985
WALLACH ZOOM COLPOSCOPE
K853389 · HEX
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 98d
Cleared Nov 19, 1985
JUMBO DIGITAL GAMMACAMERA GCA-90B WI & W2
K853470 · IYX
Toshiba Medical Systems
Radiology · 92d
Cleared Nov 19, 1985
DICOR CASTABLE CERAMIC-ALL PORCELAIN BRIDGES
K853707 · EIH
Dentsply Intl.
Dental · 76d
Cleared Nov 19, 1985
MULLER SELF LOCKING TOTAL HIP
K853768 · JDI
Protek, Inc.
Orthopedic · 71d
Cleared Nov 19, 1985
ALLOY B
K853845 · EJH
North American Alloys, Inc.
Dental · 64d