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
77305–77328 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 11, 2001
CANDELA CLEARBEAM PULSED DYE LASER
K013043 · GEX
Candela Corp.
General & Plastic Surgery · 31d
Cleared Oct 10, 2001
TITANIUM CEMENT RESTRICTOR MATERIAL PEEK
K010528 · JDK
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 229d
Cleared Oct 10, 2001
GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L
K010985 · KDI
Gambro Renal Products
Gastroenterology & Urology · 191d
Cleared Oct 10, 2001
MODIFICATION TO A620 EEG
K012011 · HCC
Stoelting Co.
Neurology · 104d
Cleared Oct 10, 2001
WIENER LAB. CREATININA CINETICA AA
K012065 · JFY
Wiener Laboratories Saic
Chemistry · 100d
Cleared Oct 10, 2001
DURACON PS LIPPED TIBIAL INSERT
K012172 · JWH
Howmedica Osteonics
Orthopedic · 90d
Cleared Oct 10, 2001
MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024
K012263 · DPS
National Custom Ent., Inc.
Cardiovascular · 84d
Cleared Oct 10, 2001
MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC
K012264 · DPS
National Custom Ent., Inc.
Cardiovascular · 84d
Cleared Oct 10, 2001
SNOWPOST, SNOWLIGHT
K012354 · ELR
Danville Materials, Inc.
Dental · 77d
Cleared Oct 10, 2001
HELIX HYDRO-JET
K012464 · FQH
Andreas Pein Medizintechnik GmbH
General Hospital · 70d
Cleared Oct 10, 2001
DISCOVERY ELBOW
K013042 · JDC
Biomet Orthopedics, Inc.
Orthopedic · 30d
Cleared Oct 10, 2001
RHODIA DENTAL PUTTY IMPRESSION MATERIAL
K013129 · ELW
Rhodia, Inc.
Dental · 21d
Cleared Oct 10, 2001
RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL
K013140 · ELW
Rhodia, Inc.
Dental · 21d
Cleared Oct 10, 2001
UNIMARK HCG COMBO PREGNANCY TEST
K013194 · JHI
Biotech Atlantic, Inc.
Chemistry · 15d
Cleared Oct 09, 2001
MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER
K010016 · BWC
Cook, Inc.
Anesthesiology · 280d
Cleared Oct 09, 2001
AUTO-LOCK
K010477 · MEG
Auto-Lock
General Hospital · 231d
Cleared Oct 09, 2001
CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031
K010954 · DQY
Concentric Medical, Inc.
Cardiovascular · 193d
Cleared Oct 09, 2001
LASER 20
K011021 · GEX
Ya-Man, Ltd.
General & Plastic Surgery · 188d
Cleared Oct 09, 2001
PHEM-ALERT
K012230 · LNW
Femtek,Llc.
Chemistry · 85d
Cleared Oct 09, 2001
VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D
K012367 · JIT
Nichols Institute Diagnostics
Chemistry · 75d
Cleared Oct 09, 2001
PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT
K012427 · EAT
Specialites Septodont
Dental · 70d
Cleared Oct 09, 2001
MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER
K012485 · CAH
King Systems Corp.
General Hospital · 68d
Cleared Oct 09, 2001
MU PHOTONICS PAIN THERAPIST
K012508 · ILY
Nu Photonics, Inc.
Physical Medicine · 64d
Cleared Oct 09, 2001
PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION...
K012509 · JIX
Phoenix Diagnostics, Inc.
Chemistry · 64d