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
136825–136848 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 29, 1988
NEPHROSS I.Q. ANDANTE
K874549 · FJI
Organon Teknika Corp.
Gastroenterology & Urology · 86d
Cleared Jan 29, 1988
KEELER ACU 22XT OPHTHALMIC CRYO UNIT
K874555 · HPS
Keeler Instruments, Inc.
Ophthalmic · 86d
Cleared Jan 29, 1988
PATIENTWATCH (TM)
K874571 · DSH
Advanced Medical Technology, Inc.
Cardiovascular · 85d
Cleared Jan 29, 1988
MOORE HIP PROSTHESIS SOLID STEM
K874599 · JDI
Orthopedic Systems, Inc.
Orthopedic · 81d
Cleared Jan 29, 1988
MOORE HIP PROSTHESIS FENESTRATED STEM
K874616 · JDI
Orthopedic Systems, Inc.
Orthopedic · 81d
Cleared Jan 29, 1988
HEALTHDYNE APNEA/HEART MONITOR, MODEL 900
K874695 · DRT
Healthdyne, Inc.
Cardiovascular · 74d
Cleared Jan 29, 1988
CAPILLARY FLOW DIALYZERS
K874728 · FJI
Baxter Healthcare Corp
Gastroenterology & Urology · 72d
Cleared Jan 29, 1988
BIPOLATOR 50
K874779 · GEI
Treace Medical, Inc.
General & Plastic Surgery · 71d
Cleared Jan 29, 1988
OMED WOUND CLOSURE STRIPS
K874813 · FPX
Oxboro Medical Intl., Inc.
General & Plastic Surgery · 66d
Cleared Jan 29, 1988
REVELATION, RADIO FLUOROSCOPIC X-RAY EXAM TABLE
K874901 · JAA
Fischer Imaging Corp.
Radiology · 59d
Cleared Jan 29, 1988
PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET
K874927 · DWC
Pioneering Technologies, Inc.
Cardiovascular · 58d
Cleared Jan 29, 1988
ADDITIONAL ALLERGENS FOR ALLERG*ENS EIA KIT
K875066 · DHB
Dexall Biomedical Labs, Inc.
Immunology · 51d
Cleared Jan 29, 1988
UNICATH LAB
K875184 · IZI
Xre Corp.
Radiology · 38d
Cleared Jan 29, 1988
MICRODISCECTOMY CURETTE SET
K875292 · FZS
T. Korossurgical Instruments Corp.
General & Plastic Surgery · 30d
Cleared Jan 29, 1988
EDEC 90C
K875342 · IZO
Electromed Intl., Ltd.
Radiology · 30d
Cleared Jan 29, 1988
OMED DISPOSABLE SCALPEL
K880028 · GDX
Oxboro Medical Intl., Inc.
General & Plastic Surgery · 24d
Cleared Jan 29, 1988
CARETEX SKID RESISTANT SHOE COVERS
K880093 · FXP
James River Corp.
General Hospital · 17d
Cleared Jan 28, 1988
ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE
K864946 · HHR
Bio Quantum Technologies, Inc.
Obstetrics & Gynecology · 407d
Cleared Jan 28, 1988
STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(594 ADHE)
K872866 · DRX
Labeltape Meditect, Inc.
Cardiovascular · 191d
Cleared Jan 28, 1988
CABOT FIBER LASER PROBE
K873115 · HET
Cabot Medical Corp.
Obstetrics & Gynecology · 171d
Cleared Jan 28, 1988
BIOTIS (TM) SABHI (DOUBLE POUR)
K874179 · KZI
Otisville Biopharm, Inc.
Microbiology · 107d
Cleared Jan 28, 1988
450SLL DEFIBRILLATOR
K874204 · LDD
Medical Research Laboratories, Inc.
Cardiovascular · 105d
Cleared Jan 28, 1988
PRE-GELLED DISPOSABLE ECG ELECTRODE - HP13941A
K874421 · DRX
Hewlett-Packard Co.
Cardiovascular · 92d
Cleared Jan 28, 1988
PRE-GELLED DISPOSABLE CLEAR TAPE ECG ELEC.HP13942D
K874422 · DRX
Hewlett-Packard Co.
Cardiovascular · 92d