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
87241–87264 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 01, 1999
VECTRA PRO MODELS 2 AND 4
K982324 · GZJ
Chattanooga Group, Inc.
Neurology · 214d
Cleared Feb 01, 1999
POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER
K982385 · KRJ
Porous Media Corp.
Cardiovascular · 207d
Cleared Feb 01, 1999
GUIDEWIRE
K982559 · DQX
Galt Medical Corp.
Cardiovascular · 193d
Cleared Feb 01, 1999
CORSAIRE
K982750 · ITI
Optiway, Inc.
Physical Medicine · 179d
Cleared Feb 01, 1999
IMPLEX SCREW AND WASHER SYSTEM
K982751 · MBI
Implex Corp.
Orthopedic · 179d
Cleared Feb 01, 1999
COOK MINI-INCUBATOR
K983642 · MQG
Cook Ob/Gyn
Obstetrics & Gynecology · 108d
Cleared Feb 01, 1999
CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S...
K983897 · HEE
Ri Mos. S.R.L.
Obstetrics & Gynecology · 90d
Cleared Feb 01, 1999
KSEA HF-SNARE
K983901 · HIH
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 90d
Cleared Feb 01, 1999
BARDEX LUBRI-SIL FOLEY CATHETER
K984084 · EZL
Bard Medical Div.
Gastroenterology & Urology · 77d
Cleared Feb 01, 1999
AESCULAP XENON LIGHT SOURCE
K984124 · FSS
Aesculap, Inc.
General & Plastic Surgery · 75d
Cleared Feb 01, 1999
PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452
K984182 · DSY
Possis Medical, Inc.
Cardiovascular · 70d
Cleared Feb 01, 1999
PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451
K984183 · DYF
Possis Medical, Inc.
Cardiovascular · 70d
Cleared Feb 01, 1999
C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER,...
K984233 · CAC
Fresenius Hemotechnology, Inc.
Anesthesiology · 68d
Cleared Feb 01, 1999
THE GOLDEN TIP ELECTRO-SURGICAL PROBE
K984275 · GEI
Amada Surgical
General & Plastic Surgery · 63d
Cleared Feb 01, 1999
CONTINUUM KNEE SYSTEM COBALT CHROMIUM ALLOY TIBIAL COMPONENT
K984291 · JWH
Implex Corp.
Orthopedic · 62d
Cleared Feb 01, 1999
ZETA MULTIZONE LOCKING NAIL SYSTEM
K984305 · HSB
Howmedica, Inc.
Orthopedic · 61d
Cleared Feb 01, 1999
SHEER THIN
K984488 · HIS
Twe Companies, Inc.
Obstetrics & Gynecology · 46d
Cleared Feb 01, 1999
STRAIGHT-IN-ORTHOPEDIC BONE SCREW FIXATION SYSTEM
K990095 · MBI
Influence, Inc.
Orthopedic · 20d
Cleared Feb 01, 1999
MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE
K990120 · HSB
Depuy Ace Medical Co.
Orthopedic · 19d
Cleared Feb 01, 1999
OSTEONICS COMBINATION SCREW RING/BLOCKER
K990158 · MNI
Osteonics Corp.
Orthopedic · 13d
Cleared Jan 29, 1999
BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K982328 · CJO
Bayer Corp.
Chemistry · 211d
Cleared Jan 29, 1999
ANGIODYNAMICS ANGIOSTENT BILIARY STENT SYSTEM
K982346 · FGE
AngioDynamics, Inc.
Gastroenterology & Urology · 207d
Cleared Jan 29, 1999
BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTACT LENS
K982947 · LPL
Ocular Sciences Puerto Rico, Inc.
Ophthalmic · 161d
Cleared Jan 29, 1999
POWER PLUS 25K MODEL, S1000, POWER PLUS 30K MODEL,S1001
K983029 · ELC
Tpc Advanced Technology, Inc.
Dental · 151d