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
74737–74760 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 2002
WELCH ALLYN ABPM 6100
K021756 · DXN
Welch Allyn, Inc.
Cardiovascular · 29d
Cleared Jun 27, 2002
L.E.DEMETRON
K021797 · EBZ
Sybron Dental Specialties, Inc.
Dental · 27d
Cleared Jun 27, 2002
BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS
K021801 · EWO
Bio-Logic Systems Corp.
Ear, Nose, Throat · 24d
Cleared Jun 26, 2002
KAVO QUATTROCARE
K012308 · EFB
Kavo America
Dental · 338d
Cleared Jun 26, 2002
GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX
K014114 · FMF
Nipro Diabetes Systems, Inc.
General Hospital · 194d
Cleared Jun 26, 2002
GARD FILTER, COMBIGARD FILTE / HME
K014281 · CAH
Munktell Filter AB
General Hospital · 181d
Cleared Jun 26, 2002
BACSTOP FILTER,BACSTOP FILTER/HME
K014282 · CAH
Munktell Filter AB
General Hospital · 181d
Cleared Jun 26, 2002
DUET SUTURE ANCHOR
K020056 · HWC
Bionx Implants, Ltd.
Orthopedic · 169d
Cleared Jun 26, 2002
BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER
K020974 · CBF
Environmental Tectonics Corp.
Anesthesiology · 92d
Cleared Jun 26, 2002
MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER
K021034 · KNT
Tfx Medical, Inc.
Gastroenterology & Urology · 89d
Cleared Jun 26, 2002
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000
K021036 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 86d
Cleared Jun 26, 2002
ERA IMPLANT
K021045 · DZE
Sterngold
Dental · 86d
Cleared Jun 26, 2002
KSEA NEUROENDOSCOPES AND ACCESSORIES
K021050 · GWG
KARL STORZ Endoscopy-America, Inc.
Neurology · 86d
Cleared Jun 26, 2002
SANARUS CENTRICA CORE TISSUE BIOPSY SYSTEM
K021137 · KNW
Sanarus Medical, Inc.
Gastroenterology & Urology · 78d
Cleared Jun 26, 2002
JUMP START, MODEL 970300
K021168 · MKJ
Medical Research Laboratories, Inc.
Cardiovascular · 76d
Cleared Jun 26, 2002
MODIFICATION TO SANARUS VISICA TREATMENT SYSTEM
K021211 · GEH
Sanarus Medical, Inc.
General & Plastic Surgery · 70d
Cleared Jun 26, 2002
BELIMED STEAM STERILIZER, MODEL TOP 5000
K021223 · FLE
Sauter AG
General Hospital · 69d
Cleared Jun 26, 2002
SOFTLASE G2-SURGICAL DIODE LASER SYSTEM
K021227 · GEX
Zap Lasers, LLC
General & Plastic Surgery · 69d
Cleared Jun 26, 2002
WARMER 2000LD
K021289 · LHC
O.R. Solutions, Inc.
General Hospital · 64d
Cleared Jun 26, 2002
CONMED HEATWAVE HAND-CONTROLLED ELETRODE
K021299 · GEI
Conmedcorp
General & Plastic Surgery · 63d
Cleared Jun 26, 2002
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K021684 · JEY
Bioplate, Inc.
Orthopedic · 35d
Cleared Jun 26, 2002
AUTOPAL 50
K021733 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 29d
Cleared Jun 26, 2002
CRITERTION, MODEL #1067511
K021741 · EJT
Sterngold
Dental · 29d
Cleared Jun 26, 2002
T2 FEMORAL NAIL
K021744 · HSB
Howmedica Osteonics Corp.
Orthopedic · 29d