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
86065–86088 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 12, 1999
LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET
K990224 · MML
Labtician Ophthalmics, Inc.
Ophthalmic · 77d
Cleared Apr 12, 1999
MSB (ELECTRICAL STIMULATION) ELECTRODES (DISPOSABLE). (TENS/FES/NMES)
K990370 · GXY
Msb,Uk
Neurology · 63d
Cleared Apr 12, 1999
REHCOR
K990813 · ISD
Electromed Corp.
Physical Medicine · 32d
Cleared Apr 12, 1999
WOUND DRESSING/ABD PAD, MODEL #10810
K990861 · NAD
Hospital Specialty Co.
General & Plastic Surgery · 27d
Cleared Apr 09, 1999
BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE
K982137 · BSZ
Blease Medical Equipment , Ltd.
Anesthesiology · 296d
Cleared Apr 09, 1999
TRACER
K982617 · MWJ
Heartland Medical Systems, Inc.
Cardiovascular · 256d
Cleared Apr 09, 1999
ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER
K984059 · FOZ
Bd Becton Dickinson Vacutainer...
General Hospital · 147d
Cleared Apr 09, 1999
ELASTYLON POWDER-FREE SURGICAL GLOVE
K984337 · KGO
Eci Medical Technologies, Inc.
General Hospital · 127d
Cleared Apr 09, 1999
TOP WHOLESOME FACE MASK
K984389 · FXX
Top Wholesome Enterprise Co., Ltd.
General Hospital · 122d
Cleared Apr 09, 1999
EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE,...
K990082 · DQA
Epic Medical Equipment Services, Inc.
Anesthesiology · 88d
Cleared Apr 09, 1999
O-RING ABUTMENT
K990277 · DZE
BioHorizons Implant Systems, Inc.
Dental · 71d
Cleared Apr 09, 1999
BIOMESH BIODEGRADABLE GTR BARRIER
K990363 · NPK
Samyang Corp.
Dental · 63d
Cleared Apr 09, 1999
BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE)
K990539 · LYY
Brightway Holdings Sdn. Bhd.
General Hospital · 46d
Cleared Apr 09, 1999
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN)
K990540 · LYY
Brightway Holdings Sdn. Bhd.
General Hospital · 46d
Cleared Apr 09, 1999
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE)
K990541 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 46d
Cleared Apr 09, 1999
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)
K990542 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 46d
Cleared Apr 09, 1999
BRIGHTWAY BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE)
K990543 · LYY
Brightway Holdings Sdn. Bhd.
General Hospital · 46d
Cleared Apr 09, 1999
MICROPLATE NEONATAL GALT ASSAY
K990827 · KQP
Bio-Rad
Chemistry · 28d
Cleared Apr 08, 1999
ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX...
K982365 · DXC
Geister Medizin Technik GmbH
Cardiovascular · 275d
Cleared Apr 08, 1999
LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM
K982940 · GEX
Star Medical Technologies, Inc.
General & Plastic Surgery · 230d
Cleared Apr 08, 1999
OMEGA II MODULAR TOTAL HIP SYSTEM
K984227 · JDI
Osteoimplant Technology, Inc.
Orthopedic · 134d
Cleared Apr 08, 1999
ACUSEAL CARDIOVASCULAR PATCH
K984526 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 108d
Cleared Apr 08, 1999
IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS...
K990302 · GIR
Instrumentation Laboratory CO
Hematology · 66d
Cleared Apr 08, 1999
TRX-CG POWER TILT AND RECLINE SYSTEM
K990544 · ITI
Motion Concepts
Physical Medicine · 45d