Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
76825–76848 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 21, 2002
ARTHROCARE CONTROLLER
K020557 · GEI
Arthrocare Corp.
General & Plastic Surgery · 29d
Cleared Mar 21, 2002
LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE
K020558 · GWM
Integra Neurosciences
Neurology · 29d
Cleared Mar 21, 2002
KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622
K020635 · MQB
Eastman Kodak Company
Radiology · 22d
Cleared Mar 21, 2002
PVS 1500 SDS
K020733 · KRA
Precision Vascular Systems, Inc.
Cardiovascular · 15d
Cleared Mar 21, 2002
CAT ACTIVE WHEELCHAIR
K020737 · IOR
Movingpeople.Net
Physical Medicine · 15d
Cleared Mar 20, 2002
RESORB-X RESORBABLE PLATING SYSTEM
K011590 · JEY
KLS-Martin L.P.
Dental · 301d
Cleared Mar 20, 2002
PELVICFLEXER EXERCISE DEVICE
K011688 · HIR
Pelvicflex, Inc.
Gastroenterology & Urology · 293d
Cleared Mar 20, 2002
DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070
K012989 · DQA
Dolphin Medical, Inc.
Anesthesiology · 195d
Cleared Mar 20, 2002
BARBITURATES
K012996 · DIS
Abbott Laboratories
Toxicology · 195d
Cleared Mar 20, 2002
METHADONE
K013001 · DJR
Abbott Laboratories
Toxicology · 195d
Cleared Mar 20, 2002
PROPOXYPHENE
K013100 · JXN
Abbott Laboratories
Toxicology · 184d
Cleared Mar 20, 2002
RAPIDONE-OXY TEST
K014101 · DJG
American Bio Medica Corp.
Toxicology · 97d
Cleared Mar 20, 2002
SULZER DENTAL CERAMIC SYSTEM-HEXLOCK
K014175 · NHA
Sulzer Dental, Inc.
Dental · 90d
Cleared Mar 20, 2002
LATEX EXAMINATION GLOVES (POWDER FREE)
K014279 · LYY
Brightway Gloves Pvt. , Ltd.
General Hospital · 83d
Cleared Mar 20, 2002
LATEX EXAMINATION GLOVE (POWDERED)
K014280 · LYY
Brightway Gloves Pvt. , Ltd.
General Hospital · 83d
Cleared Mar 20, 2002
VISUALINE BARBITURATES DIPSTRIP TEST
K020136 · DIS
Sun Biomedical Laboratories, Inc.
Toxicology · 64d
Cleared Mar 20, 2002
TOUCH&BOND-PLUS
K020239 · KLE
Parkell, Inc.
Dental · 56d
Cleared Mar 20, 2002
DAVLITE MICROENDOSCOPE & ACCESSORIES
K020310 · GCJ
Davlite Technologies
General & Plastic Surgery · 50d
Cleared Mar 20, 2002
CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC...
K020316 · DQO
Cordis Corp.
Cardiovascular · 49d
Cleared Mar 20, 2002
PASCO MIC AND MIC/ID PANELS
K020331 · JWY
Pasco Laboratories, Inc.
Microbiology · 48d
Cleared Mar 20, 2002
BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757
K020523 · SCL
Bd
General Hospital · 29d
Cleared Mar 20, 2002
PATIENTNET MONITORING SYSTEM
K020524 · MSX
General Electric Medical Systems...
Cardiovascular · 29d
Cleared Mar 20, 2002
PHILIPS MULTI-PARAMETER MODULE, MODEL M3001A
K020531 · MHX
Philips Medical Systems
Cardiovascular · 29d
Cleared Mar 20, 2002
MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER
K020590 · FLE
Getinge/Castle, Inc.
General Hospital · 26d