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
94897–94920 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 1997
AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION)
K960309 · CAW
Airsep Corp.
Anesthesiology · 420d
Cleared Feb 28, 1997
THERA-MIST NEBULIZER MODEL-P3000
K962534 · CAF
Pegasus Research Corp.
Anesthesiology · 245d
Cleared Feb 28, 1997
RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM
K963120 · DRO
Marquette Electronics, Inc.
Cardiovascular · 200d
Cleared Feb 28, 1997
CARDIACMONITOR
K963375 · DXH
Vision Electronics
Cardiovascular · 185d
Cleared Feb 28, 1997
MOBILE MEDICAL MONITOR (M3(A))
K963576 · DRT
Scientific Applications
Cardiovascular · 175d
Cleared Feb 28, 1997
QUIKSTRIP ONESTEP MARIJUANA (THC) TEST
K963654 · LDJ
Syntron Bioresearch, Inc.
Toxicology · 169d
Cleared Feb 28, 1997
CYBERLASE CO2 LASER SYSTEM
K964353 · GEX
Nidek, Inc.
General & Plastic Surgery · 119d
Cleared Feb 28, 1997
MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A
K964820 · MOS
Us Asia Instruments, Inc.
Radiology · 88d
Cleared Feb 28, 1997
ISOCAM II (DUAL HEAD GAMMA CAMERA)
K964834 · KPS
Park Medical Systems, Inc.
Radiology · 88d
Cleared Feb 28, 1997
MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL...
K964863 · EBW
Bell Intl., Inc.
Dental · 86d
Cleared Feb 28, 1997
SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SET
K964876 · FPA
Vlv Associates, Inc.
General Hospital · 85d
Cleared Feb 28, 1997
HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II
K964888 · DXH
Tz Medical, Inc.
Cardiovascular · 84d
Cleared Feb 28, 1997
HANSSON PIN SYSTEM
K964893 · JDW
Osteonics Corp.
Orthopedic · 84d
Cleared Feb 28, 1997
STRYKER SAPHENOUS VEIN HARVEST SCOPE
K964930 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 81d
Cleared Feb 28, 1997
OSTEONICS SCREW HOLE PLUGS
K965056 · JDK
Osteonics Corp.
Orthopedic · 72d
Cleared Feb 28, 1997
INTRAMEDULLARY NAIL SYSTEM
K965098 · HSB
Zimmer, Inc.
Orthopedic · 70d
Cleared Feb 28, 1997
BIPOLAR SUCTION COAGULATOR
K965241 · GEI
Kirwan Surgical Products, Inc.
General & Plastic Surgery · 79d
Cleared Feb 28, 1997
MEDNEXT SURGICAL BUR
K970023 · HWE
Mednext, Inc.
Orthopedic · 56d
Cleared Feb 28, 1997
SPINE-TECH BONE HARVESTER
K970040 · HWE
Spine-Tech, Inc.
Orthopedic · 53d
Cleared Feb 28, 1997
HA GLOBAL TAPER (GT) TAPERED HIP STEM
K970337 · MEH
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 30d
Cleared Feb 28, 1997
GLOBAL TAPER SPECTRON HIP STEMS
K970351 · JDI
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 29d
Cleared Feb 27, 1997
BEMISS JASON-STERILE,NON-STERILE,REINFORCED STERILE,AND REINFORCED...
K962666 · FYA
Bemiss-Jason Corp., Triad Medical Div.
General Hospital · 233d
Cleared Feb 27, 1997
BERGEN 610 BIPOLAR COAGULATOR
K964736 · GEI
Bergen Mfg.
General & Plastic Surgery · 94d
Cleared Feb 27, 1997
JINHUA LATEX EXAM GLOVE, POWDER FREE WITH PROTEIN LABELING
K964845 · LYY
Jinhua Latex Products Factory
General Hospital · 86d