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
146473–146496 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 03, 1985
PY-RITE
K853758 · NJH
Golden Dental Products, Inc.
Ophthalmic · 85d
Cleared Dec 03, 1985
ADULT VENTILATOR TESTER VT-1
K853760 · CBK
Bio-Tek Instruments, Inc.
Anesthesiology · 85d
Cleared Dec 03, 1985
SERIES 2000 MEDS MASK
K853785 · BSJ
Med Systems
Anesthesiology · 84d
Cleared Dec 03, 1985
PACESETTER SYS FAST PASS ENDOCARDIAL LEAD 856 INLI
K853914 · DTB
Pacesetter Systems
Cardiovascular · 71d
Cleared Dec 03, 1985
NEOGUARD CHEST PERCUSSOR
K853965 · BYI
Cas Medical Systems, Inc.
Anesthesiology · 68d
Cleared Dec 03, 1985
AMERICAN PHARMASEAL HUMIDAIR CONDENSER
K854012 · BYD
American Pharmaseal Div. Ahsc
Anesthesiology · 64d
Cleared Dec 03, 1985
COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS
K854132 · DXY
Cook Pacemaker Corp.
Cardiovascular · 54d
Cleared Dec 03, 1985
ARROW BRACHIAL CENTRAL VENOUS CATH-KIT W/16GA & EC
K854137 · DQY
Arrow Intl., Inc.
Cardiovascular · 54d
Cleared Dec 03, 1985
MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE
K854214 · DXY
Cordis Corp.
Cardiovascular · 47d
Cleared Dec 03, 1985
HEADSTRAP
K854537 · BTK
Life Design Systems, Inc.
Anesthesiology · 20d
Cleared Dec 02, 1985
SONOLAYER-L, SAL-77A
K852090 · ITX
Toshiba Medical Systems
Radiology · 203d
Cleared Dec 02, 1985
NEW OPTIONAL PROBES FOR SSA-90A
K852159 · ITX
Toshiba Medical Systems
Microbiology · 199d
Cleared Dec 02, 1985
FOUR CHANNEL PH PROBE
K853280 · FFT
Akron City Hospital
Gastroenterology & Urology · 119d
Cleared Dec 02, 1985
FLOSPIK
K853767 · JES
Medelco , Ltd.
Dental · 84d
Cleared Dec 02, 1985
WIDEX MODEL M1
K853793 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 82d
Cleared Dec 02, 1985
THE TRAVENOL 5 ML/HR INFUSOR
K853881 · FRN
Travenol Laboratories, S.A.
General Hospital · 74d
Cleared Dec 02, 1985
VISTA MED-URISTAT
K853892 · KNX
Vista Med
Gastroenterology & Urology · 74d
Cleared Dec 02, 1985
QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA
K853925 · JHI
Nms Pharmaceuticals, Inc.
Chemistry · 69d
Cleared Dec 02, 1985
1351 UROFLOW AUTO START
K853936 · FAP
Life-Tech Intl., Inc.
Gastroenterology & Urology · 69d
Cleared Dec 02, 1985
LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM
K854027 · LNK
Laserscope
Gastroenterology & Urology · 62d
Cleared Dec 02, 1985
AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER
K854028 · JIW
Verified Medical Research, Inc.
Chemistry · 62d
Cleared Dec 02, 1985
DYNAFEED
K854215 · KNT
Medline Industries, Inc.
Gastroenterology & Urology · 46d
Cleared Dec 02, 1985
MAGNETIC RETRIEVER
K854281
Aspen Laboratories, Inc.
General & Plastic Surgery · 39d
Cleared Dec 02, 1985
DEPEND FITTED BRIEF
K854378 · EYQ
Kimberly-Clark Corp.
Gastroenterology & Urology · 33d