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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
93865–93888 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 11, 1997
OLYMPUS UES-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES
K970184 · GEI
Olympus America, Inc.
General & Plastic Surgery · 84d
Cleared Apr 11, 1997
PATIENT RESTRAINT
K970272 · FMQ
Fla Orthopedics, Inc.
General Hospital · 78d
Cleared Apr 11, 1997
PATIENT RESTRAINTS
K970273 · FMQ
Fla Orthopedics, Inc.
General Hospital · 78d
Cleared Apr 11, 1997
PATIENT RESTRAINTS
K970274 · FMQ
Fla Orthopedics, Inc.
General Hospital · 78d
Cleared Apr 11, 1997
PATIENT RESTRAINTS
K970275 · FMQ
Fla Orthopedics, Inc.
General Hospital · 78d
Cleared Apr 11, 1997
MICROVASIVE GOLD PROBE
K970278 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 78d
Cleared Apr 11, 1997
B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING
K970453 · MGQ
B.Braun Medical, Inc.
General & Plastic Surgery · 79d
Cleared Apr 11, 1997
OLYMPUS NA-10J-1 ASPIRATION NEEDLE
K970563 · FCG
Olympus America, Inc.
Gastroenterology & Urology · 57d
Cleared Apr 11, 1997
LEE PLATE
K970911 · JEY
Howmedica Leibinger, Inc.
Dental · 30d
Cleared Apr 10, 1997
CARDIO TEAM II
K962937 · DXH
Vision Electronics
Cardiovascular · 255d
Cleared Apr 10, 1997
MYELOPEROXIDASE ELISA TEST SYSTEM
K964446 · MOB
Zeus Scientific, Inc.
Immunology · 155d
Cleared Apr 10, 1997
PROTEINASE-3 IGG ELISA TEST SYSTEM
K964448 · MOB
Zeus Scientific, Inc.
Immunology · 155d
Cleared Apr 10, 1997
ANCA SCREEN ELISA TEST SYSTEM
K964449 · MOB
Zeus Scientific, Inc.
Immunology · 155d
Cleared Apr 10, 1997
STERILE DISPOSABLE EQUIPMENT MAGNET COVER
K970185 · KKX
Contour Fabricators, Inc.
General Hospital · 83d
Cleared Apr 10, 1997
TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE
K970370 · FMI
Tsk Laboratory, Japan
General Hospital · 69d
Cleared Apr 10, 1997
IMMULITE THYROID AUTOANTIBODY CONTROL MODULE
K971051 · JJX
Diagnostic Products Corp.
Immunology · 17d
Cleared Apr 09, 1997
POINT-OF-CARE BLOOD GAS MONITOR SYSTEM
K961790 · CCC
Optical Sensors, Inc.
Anesthesiology · 335d
Cleared Apr 09, 1997
VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VENTRAFLO BLOOD FLOW...
K962700 · DPT
Vasamedics, LLC
Cardiovascular · 271d
Cleared Apr 09, 1997
PAP BRUSH
K963801 · HHT
Young OU Brush Co.
Obstetrics & Gynecology · 198d
Cleared Apr 09, 1997
EBI SPINELINK SYSTEM
K964533 · MNH
Electro-Biology, Inc.
Orthopedic · 148d
Cleared Apr 09, 1997
OTOSILK OTOLOGICAL GRAFT DRESSING
K964534 · NAD
Boston Medical Products, Inc.
General & Plastic Surgery · 148d
Cleared Apr 09, 1997
RELIANCE PF FEMORAL STEMS
K970200 · LZO
Howmedica Corp.
Orthopedic · 78d
Cleared Apr 09, 1997
INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER
K970492 · LKF
Ackrad Laboratories
Obstetrics & Gynecology · 58d
Cleared Apr 09, 1997
SOMNUS MODEL 615 ELECTROSURGICAL GENERATOR(MODEL 615)
K970576 · GEI
Somnus Medical Technologies, Inc.
General & Plastic Surgery · 55d