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
78193–78216 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 13, 2001
AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM
K011779 · DXN
Avid Care Corp.
Cardiovascular · 36d
Cleared Jul 13, 2001
LIFECARD CF 7 DAY
K011837 · MWJ
Reynolds Medical , Ltd.
Cardiovascular · 31d
Cleared Jul 13, 2001
ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE
K011847 · DRF
Zynergy Cardio Vasular (Zcv), Inc.
Cardiovascular · 30d
Cleared Jul 13, 2001
IN-FAST BONE SCREW SYSTEM
K011910 · HWC
American Medical Systems, Inc.
Orthopedic · 24d
Cleared Jul 13, 2001
AEQUALIS PRESS-FIT SHOULDER PROSTHESIS
K011942 · HSD
Tornier
Orthopedic · 22d
Cleared Jul 13, 2001
HOFFMAN II HYBRID RING CLAMP
K011948 · LXT
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Jul 13, 2001
IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1
K011965 · KOD
Boston Scientific Corp
Gastroenterology & Urology · 18d
Cleared Jul 13, 2001
QUANTUM BLAST
K011993 · ITI
Pride Mobility Products Corp.
Physical Medicine · 17d
Cleared Jul 13, 2001
MEDICAL DEPOT POWER NEB 1
K012006 · CAF
Medical Depot, Inc.
Anesthesiology · 16d
Cleared Jul 13, 2001
LIFESOURCE MODELS UA-787, UA 787PC, UA-787T
K012013 · DXN
A&D Engineering, Inc.
Cardiovascular · 15d
Cleared Jul 12, 2001
PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION
K000265 · JOL
Primary Care Solutions, Inc.
General Hospital · 531d
Cleared Jul 12, 2001
PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION
K000266 · JOL
Primary Care Solutions, Inc.
General Hospital · 531d
Cleared Jul 12, 2001
HA-TI (HAND TITANIUM SCREW) IMPLANT
K003045 · DZE
Hati Dental Ag.
Dental · 286d
Cleared Jul 12, 2001
IMMOBILIZATION SYSTEM FOR ENT
K003779 · IYE
Arplay Medical S.A.
Radiology · 217d
Cleared Jul 12, 2001
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
K003954 · MQV
Biocomposites, Ltd.
Orthopedic · 203d
Cleared Jul 12, 2001
INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S
K011155 · KXK
Ibt, Inc.
Radiology · 87d
Cleared Jul 12, 2001
TEMPORALSCANNER THERMOMETER, SENSORTOUCH
K011291 · FLL
Exergen Corp.
General Hospital · 76d
Cleared Jul 12, 2001
MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B
K011395 · KRH
Medtronic Vascular
Cardiovascular · 66d
Cleared Jul 12, 2001
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
K011557 · DXF
NuMED, Inc.
Cardiovascular · 52d
Cleared Jul 12, 2001
TRUBYTE DENTURE BASE RESIN SYSTEM
K011560 · EBI
Dentsply Intl.
Dental · 52d
Cleared Jul 12, 2001
PURESPERM BUFFER
K011606 · MQL
Nidacon International AB
Obstetrics & Gynecology · 49d
Cleared Jul 12, 2001
VACUETTE SAFETY BLOOD COLLECTION SET
K011786 · FMI
Greiner Vacuette North America, Inc.
General Hospital · 34d
Cleared Jul 12, 2001
DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT
K011862 · KPM
Denver Biomedical, Inc.
Gastroenterology & Urology · 28d
Cleared Jul 12, 2001
LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600
K011867 · JJY
Bio-Rad
Chemistry · 28d