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
142753–142776 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 18, 1986
INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULAR
K854845 · DSY
Intervascular, Inc.
Cardiovascular · 257d
Cleared Aug 18, 1986
TM-3400, NOMAD (MODIFIED)
K860968 · GWF
Tracor Northern, Inc.
Neurology · 160d
Cleared Aug 18, 1986
MODEL SP1465 CARDIAC OUTPUT COMPUTER
K861092 · DXG
Gould, Inc.
Cardiovascular · 147d
Cleared Aug 18, 1986
EMPTY SOLUTION TRANSFER CONTAINER 1,500 ML
K861494 · KNT
Polymer Technologies
Gastroenterology & Urology · 118d
Cleared Aug 18, 1986
LOPEZ VALVE
K861586 · MJF
Icu Medical, Inc.
General Hospital · 111d
Cleared Aug 18, 1986
OSC-80 OXIMETER
K862161 · DQA
Waters Instruments, Inc.
Anesthesiology · 73d
Cleared Aug 18, 1986
SONORANGER
K862166 · IYO
Ausonics Pty , Ltd.
Radiology · 70d
Cleared Aug 18, 1986
VISION(TM) HEMOGLOBIN
K862202 · KHG
Abbott Laboratories
Hematology · 69d
Cleared Aug 18, 1986
ESPE VISIO-MOLAR
K862292 · EBF
Espe GmbH (Us)
Dental · 62d
Cleared Aug 18, 1986
ULTRAPAC II SD (TM)
K862337 · GZJ
Medical Devices, Inc.
Neurology · 59d
Cleared Aug 18, 1986
ANU-RX
K862490 · LKX
J. & Jp., Inc.
Gastroenterology & Urology · 48d
Cleared Aug 18, 1986
ULTRACAST
K862499 · EJH
Ultratek
Dental · 48d
Cleared Aug 18, 1986
A.C.L. GUIDE KIT
K862564 · FZX
Aspen Laboratories, Inc.
General & Plastic Surgery · 46d
Cleared Aug 18, 1986
PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403
K862647 · DSK
Ivy Biomedical Systems, Inc.
Cardiovascular · 38d
Cleared Aug 18, 1986
MODIFIED DEODORANT MAXITHINS PANTY SHIELDS
K862675 · HHL
Tambrands, Inc.
Obstetrics & Gynecology · 35d
Cleared Aug 18, 1986
V. MUELLER (R) GOOSENECK CIRCULAR STAPLER
K862772 · GAG
American V. Mueller
General & Plastic Surgery · 27d
Cleared Aug 18, 1986
SPECTRUM POLYCORD I RECORDER SYSTEM
K862776 · DSH
Cardionics, Inc.
Cardiovascular · 27d
Cleared Aug 18, 1986
ABC-1000 SMALL JOINT REAMERS
K862933 · HTO
Instrumentation Industries, Inc.
Orthopedic · 14d
Cleared Aug 15, 1986
HA-2000 REAL EAR SPECTROSCOPE
K862026 · ETW
And/Or Corp.
Ear, Nose, Throat · 79d
Cleared Aug 15, 1986
RUSSIAN THISTLE ALLERGEN DISC
K862176 · DHB
Immuno Nuclear Corp.
Immunology · 67d
Cleared Aug 15, 1986
COTTONWOOD ALLERGEN DISC
K862265 · DHB
Immuno Nuclear Corp.
Immunology · 63d
Cleared Aug 15, 1986
OSTEOGRAF/AR AND OSTEOGRAF/AR+
K862324 · LYC
Coors Biomedical Co.
Dental · 57d
Cleared Aug 15, 1986
PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM
K862674 · JZT
Hybritech, Inc.
Immunology · 32d
Cleared Aug 15, 1986
MODIFIED SUPER DEODORANT MAXITHINS PADS
K862676 · HHL
Tambrands, Inc.
Obstetrics & Gynecology · 32d