FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
126385–126408 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 1990
MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS
K901018 · LIT
Boston Scientific Corp
Cardiovascular · 86d
Cleared May 30, 1990
COULTER ALBUMIN REAGENT
K901268 · CIX
Coulter Corp.
Chemistry · 75d
Cleared May 30, 1990
TABA PATIENT EXAMINATION GLOVES
K901749 · LYY
R.S.T. Corp.
General Hospital · 43d
Cleared May 30, 1990
SIEMENS SIRECUST 732, PATIENT MONITOR
K901771 · DPS
Siemens Medical Electronics
Cardiovascular · 41d
Cleared May 30, 1990
PARA 12 PLUS
K901875 · JCN
Streck Laboratories, Inc.
Hematology · 34d
Cleared May 29, 1990
LIFT MASTER PATIENT LIFT
K896848 · FNG
Henry Enterprises, Inc.
General Hospital · 175d
Cleared May 29, 1990
ULTRA-TRAC
K900575 · ITH
Practical Healthcare Devices, Inc.
Physical Medicine · 111d
Cleared May 29, 1990
COPAL VARNISH
K901049 · LBH
Pulpdent Corp.
Dental · 85d
Cleared May 29, 1990
PRELUDE (TEMPORARY CROWN AND BRIDGE CEMENT)
K901077 · EBG
Scientific Pharmaceuticals, Inc.
Dental · 83d
Cleared May 29, 1990
SPARTAN PLUS
K901098 · EJT
Ivoclar North America, Inc.
Dental · 83d
Cleared May 29, 1990
CHALLENGE 20 POWERED MUSCLE STIMULATOR
K901326 · IPF
Maximum Performance Technologies,...
Physical Medicine · 69d
Cleared May 29, 1990
MAYFLOWER BRAND PATIENT EXAMINATION GLOVES
K901376 · LYY
Kai FU Trading Co.
General Hospital · 68d
Cleared May 29, 1990
ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (ECTR)
K901617 · HRX
Smith & Nephew, Inc.
Orthopedic · 53d
Cleared May 29, 1990
RESUBMITTED ISG 3DMV WORKSTATION
K901679 · LLZ
I.S.G. Technologies, Inc.
Radiology · 47d
Cleared May 29, 1990
AUDIOTONE MODEL A-52S BEHIND-THE-EAR HEARING INST.
K901745 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 42d
Cleared May 29, 1990
AUDIOTONE ITE HEARING AID MODEL ZD (XT)
K901746 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 42d
Cleared May 29, 1990
AUDIOTONE ITE HEARING AID MODEL ZG (MIRAGE)
K901747 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 42d
Cleared May 29, 1990
AUDIOTONE ITE HEARING AID MODEL ZA (MICRO)
K901783 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 42d
Cleared May 29, 1990
KTP/532 (TM) SURGICAL LASER
K901943 · GEX
Laserscope
General & Plastic Surgery · 29d
Cleared May 29, 1990
CONTROL 1 ENVIRONMENTAL CONTROL
K902206 · ILQ
Prentke Romich Co.
Physical Medicine · 13d
Cleared May 25, 1990
EOS INLAY MATERIAL
K896469 · EBF
Ivoclar North America, Inc.
Dental · 193d
Cleared May 25, 1990
OCULAR OCCLUDER
K900942 · HOY
Microdynamics
Ophthalmic · 86d
Cleared May 25, 1990
UNIVERSUM
K900946 · LBH
Scientific Pharmaceuticals, Inc.
Dental · 85d
Cleared May 25, 1990
ORTHO CORRECTION REAGENTS
K901327 · GJT
Ortho Diagnostic Systems, Inc.
Hematology · 65d