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
90073–90096 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 1998
SIGMA DIAGNOSTICS ACCUCLOT CONTROL I
K981248 · GGN
Sigma Diagnostics, Inc.
Hematology · 23d
Cleared Apr 29, 1998
SIGMA DIAGNOSTICS ACCUCLOT CONTROL II
K981254 · GGN
Sigma Diagnostics, Inc.
Hematology · 23d
Cleared Apr 29, 1998
SIGMA DIAGNOSTICS ACCUCLOT CONTROL III
K981255 · GGN
Sigma Diagnostics, Inc.
Hematology · 23d
Cleared Apr 29, 1998
ACROMED TIMX PLATE BASED LOW BACK SYSTEM
K981274 · MNH
Acromed Corp.
Orthopedic · 21d
Cleared Apr 28, 1998
BABYPAC
K970158 · CBK
Pneupac, Inc.
Anesthesiology · 467d
Cleared Apr 28, 1998
EASY ECG PC BASED ELECTROCARDIOGRAPH
K972996 · DPS
Ates Medical S.R.L.
Cardiovascular · 259d
Cleared Apr 28, 1998
ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000)
K980346 · IPF
Universal Technology Systems, Inc.
Physical Medicine · 90d
Cleared Apr 28, 1998
VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150
K980350 · GCJ
Cuda Products Co.
General & Plastic Surgery · 90d
Cleared Apr 28, 1998
I.V. CATHETER SYSTEM
K980493 · FOZ
Johnson & Johnson Medical, Inc.
General Hospital · 78d
Cleared Apr 28, 1998
OSSEOTITE DENTAL IMPLANT SYSTEM
K980549 · DZE
Implant Innovations, Inc.
Dental · 90d
Cleared Apr 28, 1998
NTECH CYSTOSCOPES
K980592 · FAJ
N-Tech Endoscopy, Inc.
Gastroenterology & Urology · 70d
Cleared Apr 28, 1998
HYPOALLERGENIC LATEX PATIENT EXAM GLOVES-PREPOWDERED
K980848 · LYY
P.T. Irama Dinamika Latex
General Hospital · 55d
Cleared Apr 27, 1998
AUTOTRANSFUSION APPARTUS (AUTOLOG)
K972894 · CAC
Medtronic Blood Management
Anesthesiology · 265d
Cleared Apr 27, 1998
CSS-CARDIOPLEGIA SAFETY SYSTEM
K973237 · DWB
Medtronic Bio-Medicus, Inc.
Cardiovascular · 242d
Cleared Apr 27, 1998
PELVX RING, PELVX RING WITH SUPPORT
K974115 · HHW
Deschutes Medical Products, Inc.
Obstetrics & Gynecology · 178d
Cleared Apr 27, 1998
PELVX INCONTINENCE RING
K974116 · HHW
Deschutes Medical Products, Inc.
Obstetrics & Gynecology · 178d
Cleared Apr 27, 1998
PELVX DONUT, PELVX CUBE
K974117 · HHW
Deschutes Medical Products, Inc.
Obstetrics & Gynecology · 178d
Cleared Apr 27, 1998
PALFIQUE ESTELITE
K980054 · EBF
Tokuyama America, Inc.
Dental · 111d
Cleared Apr 27, 1998
TOKUSO MAC BOND II
K980058 · EBF
Tokuyama America, Inc.
Dental · 111d
Cleared Apr 27, 1998
INNOVASIVE 10MM LINX HT LIGAMENT FASTENER
K980334 · MBI
Innovasive Devices, Inc.
Orthopedic · 89d
Cleared Apr 27, 1998
MANAN VS ACCESS NEEDLE/SET
K980372 · FGE
Medical Device Technologies, Inc.
Gastroenterology & Urology · 87d
Cleared Apr 27, 1998
CLASS III REVERSE PULL FACEMASK
K980436 · DZB
Ortho Kinetics Corp.
Dental · 82d
Cleared Apr 27, 1998
EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET...
K980583 · FPA
Sims Deltec, Inc.
General Hospital · 69d
Cleared Apr 27, 1998
BIOGOLD PLUS DENTAL ALLOY
K980660 · EJT
European Dental Imports, Inc.
Dental · 66d