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
102505–102528 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 05, 1995
DEXON S, DEXON PLUS, AND DEXON II POLYGLYCOLIC ACID SUTURE
K951352 · GAM
Davis & Geck, Inc.
General & Plastic Surgery · 73d
Cleared Jun 05, 1995
KARL STORZ SUBGLOTTISCOPE, NEONATE AND INFANT, FIBER OPTIC LIGHT CARRIER,...
K951804 · CCW
KARL STORZ Endoscopy-America, Inc.
Anesthesiology · 47d
Cleared Jun 05, 1995
BIOPATH SELF-TAPPING DENTAL IMPLANT SYSTEM (5MM, 6MM)
K951937 · DZE
Bio Path
Dental · 41d
Cleared Jun 05, 1995
QCT-BONE MINERAL ANALYSIS SOFTWARE OR OCT-BMD OPTION OR OCT-5000
K952060 · KGI
Image Analysis, Inc.
Radiology · 34d
Cleared Jun 05, 1995
HEMAGEN ENA SCREENING KIT (EIA METHOD)
K952076 · LLL
Hemagen Diagnostics, Inc.
Immunology · 33d
Cleared Jun 05, 1995
HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)
K952077 · LLL
Hemagen Diagnostics, Inc.
Immunology · 33d
Cleared Jun 05, 1995
DPD DEFIBRILLATOR
K952085 · LDD
Medical Research Laboratories, Inc.
Cardiovascular · 33d
Cleared Jun 05, 1995
SONAR CIC COMPLETELY IN-THE-CANAL HEARING DEVICE
K952228 · ESD
Resound Corp.
Ear, Nose, Throat · 25d
Cleared Jun 05, 1995
PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT
K952263 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Jun 05, 1995
OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT
K952466 · JHN
Olympus America, Inc.
Immunology · 10d
Cleared Jun 02, 1995
THE SIGNATURE SERIES, M IV
K933197 · GZJ
Progressive Electrical Therapeutics
Neurology · 701d
Cleared Jun 02, 1995
PENTAX FACE MASK
K933683 · FXX
Pentax Precision Instrument Corp.
General Hospital · 673d
Cleared Jun 02, 1995
STERILE TREATMENT ELECTRODE
K941923 · GZJ
Staodyne, Inc.
Neurology · 408d
Cleared Jun 02, 1995
MODEL 511 INFANT MONITOR
K942170 · BZQ
Ge Medical Systems Information...
Anesthesiology · 394d
Cleared Jun 02, 1995
NAVIGUIDE HYDROPHILIC GUIDE WIRE
K943358 · DQX
Meadox Medicals, Div. Boston...
Cardiovascular · 325d
Cleared Jun 02, 1995
AORTIC ARCH CANNULAS
K943934 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 294d
Cleared Jun 02, 1995
7050 ULTRASOUND IMAGING SYSTEM
K944287 · ITX
Biosound, Inc.
Radiology · 273d
Cleared Jun 02, 1995
MODEL 3200 VASCULAR MINI-LAB
K944495 · MHX
Parks Medical Electronics, Inc.
Cardiovascular · 262d
Cleared Jun 02, 1995
W&H 895 TOP LIGH HIGHSPEED FIBEROPTIC SINGLE SPRAY
K944708 · EFB
A-Dec, Inc.
Dental · 252d
Cleared Jun 02, 1995
W&H 898 TOP LIGHT HIGHSPEED
K944710 · EFB
A-Dec, Inc.
Dental · 252d
Cleared Jun 02, 1995
W&H 795 TOP AIR TURBINE SINGLE SPRAY
K944715 · EFB
A-Dec, Inc.
Dental · 252d
Cleared Jun 02, 1995
W&H 796 TOP AIR TURBINE MINI-HEAD
K944716 · EFB
A-Dec, Inc.
Dental · 252d
Cleared Jun 02, 1995
W&H 798 TOP AIR TURBINE TRIPLE SPRAY
K944717 · EFB
A-Dec, Inc.
Dental · 252d
Cleared Jun 02, 1995
PIDURAL STEROID SYSTEM
K945484 · CAZ
Professional Medical Device Consultants
Anesthesiology · 206d