FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
143905–143928 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 1986
ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY)
K861483 · DQO
Mallinckrodt Critical Care
Cardiovascular · 28d
Cleared May 14, 1986
NEO-TRAK 502 INFANT MONITOR
K861407 · BZQ
Ge Medical Systems Information...
Anesthesiology · 29d
Cleared May 14, 1986
CANON AUTO REF KERATOMETER RK-1
K861415
Canon USA, Inc.
Ophthalmic · 29d
Cleared May 14, 1986
CANON AUTO ACUITOMETER CV-10
K861416 · HOX
Canon USA, Inc.
Ophthalmic · 29d
Cleared May 14, 1986
OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU
K861535 · HMR
CooperVision, Inc.
Ophthalmic · 20d
Cleared May 13, 1986
AMUCHINA/DIALYZER DISINFECTANT
K852359 · FKQ
Amuchina Intl., Inc.
Gastroenterology & Urology · 343d
Cleared May 13, 1986
TRANSCOR (TM) RADIO-STETHOSCOPE
K854772 · DQD
K & S Medicorp
Cardiovascular · 165d
Cleared May 13, 1986
TRANSURETHAL PROSTATOME DIAG TREATM PROPULSION SYS
K855176 · FBK
Urologic Surgical Devices Corp.
Radiology · 138d
Cleared May 13, 1986
CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT
K860279 · LIN
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 119d
Cleared May 13, 1986
THE CMV-IGM TEST
K860450 · LKQ
Microbiological Research Corp.
Microbiology · 98d
Cleared May 13, 1986
YEAST IDENTIFICATION PANEL
K860575 · JXB
American Micro Scan
Microbiology · 84d
Cleared May 13, 1986
DIRECTIGEN COMBO MENINGITIS TEST
K860768 · GTZ
Bd Becton Dickinson Vacutainer...
Microbiology · 71d
Cleared May 13, 1986
LEECO-SCREEN, STREP A (EIA)
K860947 · GTZ
Leeco Diagnostics, Inc.
Microbiology · 62d
Cleared May 13, 1986
ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY
K860990 · FGE
Endovations
Gastroenterology & Urology · 57d
Cleared May 13, 1986
LEADS UTILIZ VOLUN STAND #1 3.2 MM UNI/BIOPOLAR CO
K861440 · DTB
Pacesetter Systems
Cardiovascular · 26d
Cleared May 13, 1986
ALISUN -TYPE 1200, TYPE 1000/800 AND TYPE 700/900
K861447 · FTC
Southern Exposure, Inc.
General & Plastic Surgery · 26d
Cleared May 13, 1986
MONOSTAR SYSTEM: IM LATEX TEST
K861452 · KTN
U.S. Health Resources Corp.
Immunology · 25d
Cleared May 13, 1986
ALPHA TAN 1000 AND ALPHA TAN 1200
K861570 · FTC
Midwest Marketing Service
General & Plastic Surgery · 15d
Cleared May 13, 1986
ULTRACLONE 01-2300 CELL LINE
K861585 · KIR
Earl-Clay Laboratories, Inc.
Pathology · 14d
Cleared May 13, 1986
VICKERS ERGOMATIC MICROSURG INSTRU CARDIAC SET
K861745 · DWS
Keeler Instruments, Inc.
Cardiovascular · 7d
Cleared May 12, 1986
MONARCH II BLEACHING INSTRUMENT
K854692 · EEG
Almore Intl., Inc.
Dental · 172d
Cleared May 12, 1986
DENCLENZ
K854995 · EFT
Creighton Products Corp.
Dental · 151d
Cleared May 12, 1986
OSCILLOMATE NEONATAL BLOOD PRESS. MONIT.-MODEL 901
K860196 · DXN
Cas Medical Systems, Inc.
Cardiovascular · 110d
Cleared May 12, 1986
ISO-THERMEX
K861100 · FLL
Columbus Instruments Intl. Corp.
General Hospital · 49d