FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
87505–87528 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 07, 1999
FIELD EFFECTS MRI SYSTEM
K983902 · LNH
Intermagnetics General Corp.
Radiology · 65d
Cleared Jan 07, 1999
LIGHT AGE EPICARE ALEXANDRITE LASER
K983977 · GEX
Light Age, Inc.
General & Plastic Surgery · 59d
Cleared Jan 07, 1999
FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS
K984068 · ESW
Schneider (Europe) GmbH
Gastroenterology & Urology · 52d
Cleared Jan 07, 1999
FLUOROTEX SURGICAL MESH
K984197 · FTL
Bridger Biomed, Inc.
General & Plastic Surgery · 45d
Cleared Jan 07, 1999
MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M
K984435 · KRH
Medtronic Vascular
Cardiovascular · 27d
Cleared Jan 07, 1999
MODIFIED AUTO SUTURE*VCS** ANASTOMOTIC**CLIP CARTRIDGE
K984438 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 24d
Cleared Jan 06, 1999
NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM
K982928 · CHL
Radiometer America, Inc.
Chemistry · 139d
Cleared Jan 06, 1999
PRECISION UV (VASURFILCON A)
K982988 · LPL
Wesley Jessen Corp.
Ophthalmic · 133d
Cleared Jan 06, 1999
OSSEOTITE DENTAL IMPLANTS
K983347 · DZE
Implant Innovations, Inc.
Dental · 105d
Cleared Jan 06, 1999
BIOCLOT APC SENSITIVITY
K983898 · GGP
Biopool Intl., Inc.
Hematology · 64d
Cleared Jan 06, 1999
DUAL VIAL CREATININE REAGENT
K983937 · CGX
Intersect Systems, Inc.
Chemistry · 62d
Cleared Jan 06, 1999
MODIFICATION OF TSRH SPINAL SYSTEM
K984522 · MNI
Danek Medical, Inc.
Orthopedic · 16d
Cleared Jan 05, 1999
SYSTEM U3 FOR NITROFURANTOIN
K983565 · JWY
Ab Biodisk
Microbiology · 84d
Cleared Jan 04, 1999
HEWLETT-PACKARD M1205A VIRIDIA 24 CT
K981376 · DSI
Hewlett-Packard Co.
Cardiovascular · 263d
Cleared Jan 04, 1999
STATIM 5000 CASSETTE AUTOCLAVE
K983679 · FLE
Scican
General Hospital · 76d
Cleared Dec 31, 1998
ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS
K981680 · FIP
Dayton Water Systems
Gastroenterology & Urology · 232d
Cleared Dec 31, 1998
INSTATRAK 3000
K983529 · LLZ
Visualization Technology, Inc.
Radiology · 84d
Cleared Dec 31, 1998
'RAPID DRUG SCREEN' 9-PANEL
K983770 · DKZ
American Bio Medica Corp.
Chemistry · 66d
Cleared Dec 31, 1998
DEPUY ACE SPIDER PLATE
K984458 · HRS
Depuy Ace Medical Co.
Orthopedic · 16d
Cleared Dec 30, 1998
MOUNTABLE ENDOSCOPIC KNIFE
K982142 · EMF
A.M. Surgical, Inc.
General & Plastic Surgery · 196d
Cleared Dec 30, 1998
RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC
K982549 · IYE
Radionics, Inc.
Radiology · 162d
Cleared Dec 30, 1998
ROCS TPS
K982791 · MUJ
Radiation Oncology Computer Systems
Radiology · 142d
Cleared Dec 30, 1998
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20,...
K983055 · LIT
Guidant Corp.
Cardiovascular · 120d
Cleared Dec 30, 1998
DIGORA FOR WINDOWS 2.0
K983267 · MUH
Orion Corporation Soredex
Radiology · 104d