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
104641–104664 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 1995
UNITRON MODEL VISTA 1000 SIGMA, AIR CONDUCTION HEARING AID
K946323 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 32d
Cleared Jan 30, 1995
ALTERNATE 100% ETO STERILIZATION PROCESS AND ALTERNATE STERILIZATION FACCILITY
K950127 · GZB
Medtronic Vascular
Neurology · 18d
Cleared Jan 27, 1995
APOLLO KNEE FEMORAL COMPONENT
K933229 · JWH
Intermedics Orthopedics
Orthopedic · 574d
Cleared Jan 27, 1995
TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION
K933995 · HSB
Applied Osteo Systems, Inc.
Orthopedic · 528d
Cleared Jan 27, 1995
PROLEX (STREPTOCCAL GROUPING LATEX KIT)
K934383 · GTZ
Pro-Lab, Inc.
Microbiology · 505d
Cleared Jan 27, 1995
STRATO MEDICAL INFUSE-A-PORT/INFUSE-A-KIT PERIPORT PERIPHERAL ACCESS SYSTEM
K934518 · LJT
Strato Medical Corp.
General Hospital · 497d
Cleared Jan 27, 1995
ARGYLE SALEM SUMP TUBE ANTI-REFLUX VALVE INSERTION TRAY
K935781 · FEG
Sherwood Medical Co.
Gastroenterology & Urology · 417d
Cleared Jan 27, 1995
DIDECO VACUUM PUMP
K936220 · CAC
Dideco
Anesthesiology · 395d
Cleared Jan 27, 1995
BBL CRYSTAL MRSA ID SYSTEM
K941997 · JWY
Becton Dickinson Microbiology Systems
Microbiology · 277d
Cleared Jan 27, 1995
DRAGER-VAPOR 19.1
K942055 · CAD
North American Grager
Anesthesiology · 274d
Cleared Jan 27, 1995
SAFE VENT SYSTEM
K942394 · FMF
Incutech, Inc.
General Hospital · 253d
Cleared Jan 27, 1995
M4 CONTRA-ANGLE HANDPIECE
K942480 · EGS
Kerr Corporation (Danbury)
Dental · 247d
Cleared Jan 27, 1995
CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER
K942546 · DXN
Dynatech/Nevada, Inc.
Cardiovascular · 241d
Cleared Jan 27, 1995
SORIN BLOOD CARDIOPLEGIA CONSOLE
K942582 · DTQ
Sorin Biomedical, Inc.
Cardiovascular · 240d
Cleared Jan 27, 1995
CHOLESTEROL QVET
K943027 · CHH
Prisma Systems
Toxicology · 214d
Cleared Jan 27, 1995
TRIMLINE 2000
K943081 · DXN
Pymah Corp.
Cardiovascular · 213d
Cleared Jan 27, 1995
DEPUY AMK ALL POLYETHYLENE POSTERIOR STABLILIZED TIBIAL TRAY
K943299 · JWH
Depuy, Inc.
Orthopedic · 202d
Cleared Jan 27, 1995
RAPID YEAST PLUS SYSTEM
K943621 · JXB
Innovative Diagnostic Systems, Inc.
Microbiology · 184d
Cleared Jan 27, 1995
EXTERNAL FIXATOR
K943857 · JEC
Acu Med, Inc.
Orthopedic · 172d
Cleared Jan 27, 1995
IMPLANTECH NASAL LABIAL IMPLANT
K943988 · LZK
Implantech Associates, Inc.
General & Plastic Surgery · 164d
Cleared Jan 27, 1995
SHARPS CONTAINER 18 GALLON
K944121 · FMI
Bci, Inc.
General Hospital · 157d
Cleared Jan 27, 1995
PY30, PY60, PY80
K944928 · GEX
Huttinger Medizintechnik GmbH & CO KG
General & Plastic Surgery · 113d
Cleared Jan 27, 1995
CUSTOM MEDICAL SUSPENSION STRAP
K944988 · JAY
Custom Medical Specialties, Inc.
Anesthesiology · 107d
Cleared Jan 27, 1995
CONSENUS HIP SYSTEM -- ACETABULAR REAMER
K945186 · HWE
U.S. Medical Products, Inc.
Orthopedic · 95d