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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
148297–148320 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 1985
VIROGEN RUBELLA MICROTITER TEST
K844436 · LQN
Armkel, LLC
Microbiology · 186d
Cleared May 21, 1985
QUANTUM 84
K844707 · GWF
Cadwell Laboratories, Inc.
Neurology · 169d
Cleared May 21, 1985
EUROPLATE-CONDUCTIVE ADHESIVE ELECTROSURGICAL RETU
K844780 · GEI
Poly- Med, Inc.
General & Plastic Surgery · 162d
Cleared May 21, 1985
OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT
K844854 · DQO
Vas-Cath of Canada , Ltd.
Cardiovascular · 159d
Cleared May 21, 1985
Z0174, IMPEDANCE AUDIOMETER
K845049 · ETY
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 176d
Cleared May 21, 1985
PROVAC WOUND HEALING/SUCTION SET
K850011 · GCY
Medical Matrix, Inc.
General & Plastic Surgery · 139d
Cleared May 21, 1985
AUTO TURNER
K850419 · FNM
George J. Kamilar
General Hospital · 106d
Cleared May 21, 1985
ABSORBABLE INTRACANALICULAR COLLAGEN IMPLANT
K850649
Lacrimedics, Inc.
Ophthalmic · 91d
Cleared May 21, 1985
ARGYLE GRIFFITH TDMAC HEPARINIZED VENO-VENOUS SHUN
K850917 · DWF
Sherwood Medical Co.
Cardiovascular · 77d
Cleared May 21, 1985
BLOOD TUBING(PVC) 201458 W/(TOTM) PLASTICIZER
K850925 · DWF
American Bentley
Cardiovascular · 77d
Cleared May 21, 1985
XRO UMBILICAL CATHETER-CODE 270
K851005 · FOS
Vygon Corp.
General Hospital · 70d
Cleared May 21, 1985
T-SWIPE -TONGUE CLEANER
K851006 · LCN
Kumar Ent.
Dental · 70d
Cleared May 21, 1985
MAYFIELD TABLE-ELECTRIC
K851021 · GDC
Ohio Medical Instrument Co., Inc.
General & Plastic Surgery · 70d
Cleared May 21, 1985
MOI-STIR ORAL SWABSTICK(S)
K851026 · LFD
Kingswood Laboratories, Inc.
Dental · 70d
Cleared May 21, 1985
CANON X-RAY FILM CHANGER CFC-U1
K851067 · KPX
Canon USA, Inc.
Radiology · 64d
Cleared May 21, 1985
VICRYL (POLYGLACTIN 910/MERSILENE COMPOISITE MESH
K851086 · FTM
Ethicon, Inc.
General & Plastic Surgery · 64d
Cleared May 21, 1985
PHADEBAS RAST PHADEZYM RAST ALLERTUBES
K851273 · DHB
Pharmacia, Inc.
Chemistry · 50d
Cleared May 21, 1985
MICROCOR ECG MONITOR
K851325 · DRT
Microcor, Inc.
Cardiovascular · 47d
Cleared May 21, 1985
HA-1000 & HA-500 HYDROXYLAPATITE-MODIFICATION
K851367 · DZE
Orthomatrix, Inc.
Chemistry · 46d
Cleared May 21, 1985
TRANDUCER PROTECTOR
K851428 · FIB
Galvin Industries, Inc.
Gastroenterology & Urology · 41d
Cleared May 21, 1985
VISILUX 2 VISIBLE LIGHT CURING UNIT
K851459 · EBF
3M Company
Dental · 40d
Cleared May 21, 1985
SPECTRUM 150 DT
K851644 · IYX
Raytheon Medical Systems
Radiology · 32d
Cleared May 21, 1985
PACESETTER SYSTEMS, MODEL 458 ADAPTER SLEEVE
K851665 · DTD
Pacesetter Systems
Cardiovascular · 29d
Cleared May 21, 1985
LARYNGOSCOPE
K851705 · CCW
Armstrong Ind., Inc.
Anesthesiology · 26d