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
143497–143520 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 06, 1986
SIGNA II RESTING ECG ELECTRODE
K862655 · DRX
Kone Instruments, Inc.
Cardiovascular · 23d
Cleared Aug 06, 1986
FLOSS CARD
K862694 · JES
Floss Card Co.
Dental · 22d
Cleared Aug 06, 1986
EM DIAGNOSTIC ECG ELECTRODE
K862746 · DRX
Electromed Intl., Ltd.
Cardiovascular · 16d
Cleared Aug 06, 1986
PREGELLED INFANT DISPOSABLE ECG ELECTRODE
K862756 · DXN
Labeltape Meditect, Inc.
Cardiovascular · 15d
Cleared Aug 06, 1986
EUROMED S-601
K862765 · DRX
Lectec Corp.
Cardiovascular · 15d
Cleared Aug 06, 1986
MEDCOMP C.A.V.H. CATHETER
K862771 · LFK
Medical Components, Inc.
Gastroenterology & Urology · 15d
Cleared Aug 06, 1986
SYRINGE INJECTION GUN
K862853
Gastrotech, Inc.
General & Plastic Surgery · 8d
Cleared Aug 05, 1986
CORDIS ANCOR ACTIVE FIXATION LEAD
K832422 · DTB
Cordis Corp.
Cardiovascular · 1110d
Cleared Aug 05, 1986
CORDIS HI-FLEX PERVENOUS ACTIVE FIXATION UNIPOLAR
K851064 · DTB
Cordis Corp.
Cardiovascular · 508d
Cleared Aug 05, 1986
UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO
K861984 · DYB
Universal Medical Instrument Corp.
Cardiovascular · 75d
Cleared Aug 05, 1986
6000 ND:YAG LASER FOR BENIGN/MALIGNANT OBSTRUCTION
K862698 · LLO
Cooper Lasersonics, Inc.
Anesthesiology · 21d
Cleared Aug 04, 1986
DIAGEM 300 BG REAGENT STRIPS
K854329 · CGA
Seton Products, Inc.
Chemistry · 280d
Cleared Aug 04, 1986
DIATRON BLOOD GLUCOSE METER
K855178 · CGA
Dextron, Inc.
Chemistry · 221d
Cleared Aug 04, 1986
AMPU-PAK
K860511 · LPZ
Ammerman Medical Enterprises, Inc.
General Hospital · 174d
Cleared Aug 04, 1986
IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN
K860679 · DCN
Orion Corp.
Immunology · 160d
Cleared Aug 04, 1986
FORETEL, COLOR OVULATION TEST
K860828 · CEP
Nms Pharmaceuticals, Inc.
Chemistry · 152d
Cleared Aug 04, 1986
MIKROS, MIKROS VS-1, PULSE GENERATOR
K860922 · DXY
Biotronik Sales, Inc.
Cardiovascular · 146d
Cleared Aug 04, 1986
MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR
K861368 · JOQ
Medtronic Vascular
Cardiovascular · 115d
Cleared Aug 04, 1986
PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST
K861974 · LNJ
Perceptive Systems, Inc.
Pathology · 75d
Cleared Aug 04, 1986
LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL
K862185 · JJY
Bio-Rad
Chemistry · 56d
Cleared Aug 04, 1986
TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER
K862206 · JJJ
Micromedic Systems
Chemistry · 55d
Cleared Aug 04, 1986
AMIKACIN KIT (FPIA)
K862248 · LGJ
Windsor Laboratories, Inc.
Toxicology · 53d
Cleared Aug 04, 1986
GAS-TRAK
K862278 · JJY
United Diagnostics, Inc.
Chemistry · 49d
Cleared Aug 04, 1986
UTAK-STABBS TOXICOLOGY CONTROL
K862420 · JJY
Utak Laboratories, Inc.
Toxicology · 40d