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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
73513–73536 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 19, 2003
BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY...
K030354 · EBD
Bisco, Inc.
Dental · 16d
Cleared Feb 14, 2003
EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS...
K022071 · DTM
Embol-X, Inc.
Cardiovascular · 233d
Cleared Feb 14, 2003
STEERABLE GUIDEWIRE
K022813 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 172d
Cleared Feb 14, 2003
RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO...
K023050 · IMG
Reliant Technologies, Inc.
Physical Medicine · 154d
Cleared Feb 14, 2003
ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR
K023407 · CGX
Elan Diagnostics
Chemistry · 127d
Cleared Feb 14, 2003
PLATELETWORKS, MODELS PW-A, PW-C
K023761 · JOZ
Helena Laboratories
Hematology · 98d
Cleared Feb 14, 2003
TAI-CHI AND MASTER ACUPUNCTURE NEEDLES
K023787 · MQX
Lhasa Medical, Inc.
General Hospital · 93d
Cleared Feb 14, 2003
ALBUMIN COBALT BINDING TEST (ACB TEST)
K023824 · NJV
Ischemia Technologies, Inc.
Chemistry · 88d
Cleared Feb 14, 2003
SMARTSTITCH M-CONNECTOR, MODEL OM-8005
K023843 · OCW
Opus Medical, Inc.
Gastroenterology & Urology · 88d
Cleared Feb 14, 2003
MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER...
K023848 · MOS
Igc-Medical Advances, Inc.
Radiology · 87d
Cleared Feb 14, 2003
SAMARITAN AED, MODEL SAM-01
K023854 · MKJ
Heartsine Technologies, Inc.
Cardiovascular · 87d
Cleared Feb 14, 2003
ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE
K023953 · EGS
St. George Technology, Inc.
Dental · 79d
Cleared Feb 14, 2003
CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR...
K024045 · LPL
Contamac, Ltd.
Ophthalmic · 70d
Cleared Feb 14, 2003
GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM
K024071 · NHW
Guidant Corporation, Cardiac Surgery
Cardiovascular · 66d
Cleared Feb 14, 2003
4 SEASONS
K024094 · EBF
Ivoclar Vivadent, Inc.
Dental · 65d
Cleared Feb 14, 2003
SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS...
K024097 · CAC
Summit Medical , Ltd.
Anesthesiology · 64d
Cleared Feb 14, 2003
SURGICAL TITANIUM MESH SYSTEM
K030249 · MQP
Depuyacromed
Orthopedic · 21d
Cleared Feb 13, 2003
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS02-5
K021588 · IPF
Biomedical Life Systems, Inc.
Physical Medicine · 275d
Cleared Feb 13, 2003
MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX
K022815 · LYY
Pt. Smartglove Indonesia
General Hospital · 171d
Cleared Feb 13, 2003
6203
K022865 · NFB
Contemporary Products, Inc.
Anesthesiology · 169d
Cleared Feb 13, 2003
SMARTSET HV BONE CEMENT
K023012 · LOD
DePuy Orthopaedics, Inc.
Orthopedic · 156d
Cleared Feb 13, 2003
POWDER FREE NITRILE EXAMINATION GLOVES, PURPLE COLOR
K023072 · LZA
Arista Latindo Industrial Ltd. P.T
General Hospital · 150d
Cleared Feb 13, 2003
ALOE VERA & VITAMIN E POWDERFREE LATEX EXAMINATION GLOVES
K023974 · LYY
Top Glove Sdn. Bhd.
General Hospital · 73d
Cleared Feb 13, 2003
N LATEX IGA
K024038 · CZP
Dade Behring, Inc.
Immunology · 69d