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
119425–119448 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 16, 1991
POLARIS, ORAL INDICATION
K912063 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 160d
Cleared Oct 16, 1991
MODEL #911 STEALTH MULTI PADS
K912621 · LDD
Cardiotronics, Inc.
Cardiovascular · 125d
Cleared Oct 16, 1991
DORNIER LASER LITHOTRIPTER IMPACT
K913191 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 90d
Cleared Oct 16, 1991
MODEL 100 CENTRAL STATION
K913193 · DQK
Protocol Systems, Inc.
Cardiovascular · 90d
Cleared Oct 16, 1991
WRISTRECORDER CARDIAC EVENT RECORDING SYSTEM
K913600 · DSH
Ralin Laboratories, Inc.
Cardiovascular · 64d
Cleared Oct 16, 1991
SUB-4(TM), PERIPHERAL DILATATION CATHETER
K913689 · LIT
Boston Scientific Corp
Cardiovascular · 58d
Cleared Oct 16, 1991
CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL
K913801 · DYB
Cordis Corp.
Cardiovascular · 51d
Cleared Oct 15, 1991
CHALLENGE 4010 ONE CHANNEL WIDE PULSE STIMULATOR
K904360 · IPF
Maximum Performance Technologies,...
Physical Medicine · 386d
Cleared Oct 15, 1991
TEAM-MC
K905672 · GZJ
Henley Intl.
Neurology · 301d
Cleared Oct 15, 1991
SATURATION/HEMATOCRIT MONITOR SYSTEM
K910421 · DRY
Medtronic Vascular
Cardiovascular · 258d
Cleared Oct 15, 1991
MARKSMAN ARTERIAL BLOOD GAS SYRINGE
K910970 · JKA
Martech Medical Products, Inc.
Chemistry · 222d
Cleared Oct 15, 1991
DATASCOPE PASSPORT MONITOR
K911598 · DRT
Datascope Corp.
Cardiovascular · 189d
Cleared Oct 15, 1991
COMPUTER ASSIST STEREOTACTIC SURG SYST, MODIFIED
K911750 · IYE
Medical Instrumentation & Diagnostics...
Radiology · 180d
Cleared Oct 15, 1991
OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM
K911770 · BTT
Automatic Liquid Packaging, Inc.
Anesthesiology · 179d
Cleared Oct 15, 1991
AXION 5, MODIFICATION
K911814 · GZJ
Ventura Medical Electronics
Neurology · 181d
Cleared Oct 15, 1991
PHILIPS ANGIOPRO
K911888 · IZP
Philips Medical Systems North...
Radiology · 169d
Cleared Oct 15, 1991
WIZARD STERILIZED ELECTROEPILATION NEEDLE
K911983 · KCW
Skin Deep, Inc.
General & Plastic Surgery · 165d
Cleared Oct 15, 1991
ULTRASOUND STETHOSCOPE(R) INTRADOP(R)
K912033 · JAF
Medadonics, Inc.
Radiology · 159d
Cleared Oct 15, 1991
VITALOGRAPH SPIROTRAC III
K912412 · BZG
Vitalograph , Ltd.
Anesthesiology · 137d
Cleared Oct 15, 1991
HOME MEDICAL KIT - FOR LITTLE HURTS
K912684 · MCY
Great West Medical Equipment, Inc.
General & Plastic Surgery · 123d
Cleared Oct 15, 1991
TRUE/FLEX TIBIAL RODS WITH CAP
K912710 · HSB
Applied Osteo Systems, Inc.
Orthopedic · 118d
Cleared Oct 15, 1991
OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS)
K912763 · BYX
Medical Fittings, Inc.
Anesthesiology · 113d
Cleared Oct 15, 1991
MEDICAM LAPAROSCOPY ENDOSCOPES
K912933 · GCJ
Kirschner Medical Corp.
General & Plastic Surgery · 102d
Cleared Oct 15, 1991
GYROVIEW-HR
K913029 · JAK
Philips Medical Systems, Inc.
Radiology · 98d