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

Filters: Cleared only ×
175,820 results
146809–146832 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 04, 1985
BEAVER R-K KNIFE
K852828 · HNN
Rudolph Beaver, Inc.
Ophthalmic · 125d
Cleared Nov 04, 1985
SMARTKNIFE SYSTEM
K853063 · HNN
CooperVision, Inc.
Ophthalmic · 108d
Cleared Nov 04, 1985
88000 GASTROSTOMY-JEJUNAL FEEDING TUBE KIT
K853353 · KNT
Superior Healthcare Group, Inc.
Gastroenterology & Urology · 84d
Cleared Nov 04, 1985
STORZ DIAMOND KNIFE
K853403 · HNN
Storz Instrument Co.
Ophthalmic · 84d
Cleared Nov 04, 1985
OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE
K853598 · HNN
Myocure, Inc.
Ophthalmic · 69d
Cleared Nov 04, 1985
ENDODYNAMIC SIEGEL SPHINCTEROTOME
K853680 · KNS
E-Z-Em, Inc.
Gastroenterology & Urology · 61d
Cleared Nov 04, 1985
UCD URINE SPECIMEN COLLECTOR
K854173 · KNX
Baker Instructions Corp.
Gastroenterology & Urology · 20d
Cleared Nov 01, 1985
TRAVENOL MULTIDAY INFUSOR 2C1080
K842905 · FRN
Travenol Laboratories, S.A.
General Hospital · 465d
Cleared Nov 01, 1985
ANTISERUM TO HUMAN PREALBUMIN
K850686 · JZJ
Kent Laboratories, Inc.
Immunology · 253d
Cleared Nov 01, 1985
ANTISERUM TO HUMAN APOLIPOPROTEIN B
K850690 · MSJ
Kent Laboratories, Inc.
Immunology · 253d
Cleared Nov 01, 1985
ANTISERUM TO HUMAN APOLIPOPROTEIN A-I
K850691 · MSJ
Kent Laboratories, Inc.
Immunology · 253d
Cleared Nov 01, 1985
PERCUTANEOUS GREENFIELD VENA CAVA FILTER SYSTEM
K852097 · DTK
Medi-Tech, Inc.
Cardiovascular · 170d
Cleared Nov 01, 1985
ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER
K852115 · FLF
Ars Enterprises, Inc.
General Hospital · 170d
Cleared Nov 01, 1985
DISPOSABLE STEAM BIOLOGICAL TEST PACK
K852192 · FRC
Parke-Davis Co.
General Hospital · 165d
Cleared Nov 01, 1985
FAP-CATH
K852456 · DQO
Research Medical, Inc.
Cardiovascular · 144d
Cleared Nov 01, 1985
MEDTRONICS MODELS 8320/8322/8329
K852688 · DXY
Medtronic Vascular
Cardiovascular · 129d
Cleared Nov 01, 1985
CORDIS MODELS 336A,336B,337A & 334 CARDIAC PACEMAK
K852748 · DXY
Cordis Corp.
Cardiovascular · 127d
Cleared Nov 01, 1985
STERICOVER
K853044 · IZI
Sterimed, Inc.
Radiology · 105d
Cleared Nov 01, 1985
MALLORY/HEAD TOTAL HIP SYSTEM
K853259 · KMC
Biomet, Inc.
Orthopedic · 91d
Cleared Nov 01, 1985
DUROMEDICS CARDIAC VALVE SIZER SET
K853313 · DTI
Hemex Scientific, Inc.
Cardiovascular · 86d
Cleared Nov 01, 1985
RMS-1000 A.K.A. RAYTHEON MEDICAL SYSTEMS-1000
K853395 · IZH
Raytheon Medical Systems
Radiology · 81d
Cleared Nov 01, 1985
LASER IRAS
K853556 · HPJ
Randwal Instrument Co., Inc.
Ophthalmic · 67d
Cleared Nov 01, 1985
VESSA TREKKA
K853595 · ITI
Vessa , Ltd.
Physical Medicine · 66d
Cleared Nov 01, 1985
PERSONAL AMPLIFIER SLIMLINE III
K853605 · ESD
Electone, Inc.
Ear, Nose, Throat · 65d