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
92305–92328 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 19, 1997
ORIGIN CARDIAC STABLIZER OCCLUDER
K970611 · DXC
Origin Medsystems, Inc.
Cardiovascular · 182d
Cleared Aug 19, 1997
CRYO CHECK APC RESISTANT PLASMA
K971222 · GGN
Precision Biologicals, Inc.
Hematology · 139d
Cleared Aug 19, 1997
ASSERACHROM TPA TEST KIT
K971519 · GGP
American Bioproducts Co.
Hematology · 116d
Cleared Aug 19, 1997
LACTOSORB TRAUMA PLATING SYSTEM
K971870 · HRS
Biomet, Inc.
Orthopedic · 90d
Cleared Aug 19, 1997
ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR
K972371 · CAF
Brasamerica Medical Equipment, Inc.
Anesthesiology · 55d
Cleared Aug 19, 1997
IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3)
K972861 · JJS
Instrumentation Laboratory CO
Chemistry · 15d
Cleared Aug 18, 1997
ROOTFORM DENTAL IMPLANT SYSTEM
K954758 · DZE
Swiss Dental Center
Dental · 672d
Cleared Aug 18, 1997
EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE...
K961942 · GYC
Radionics, Inc.
Neurology · 455d
Cleared Aug 18, 1997
TRACCELL 2000 SLIDE MAPPING SYSTEM
K964689 · JOY
Accumed Intl., Inc.
Hematology · 269d
Cleared Aug 18, 1997
CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM
K965140 · DQX
Cardio Metrics, Inc.
Cardiovascular · 238d
Cleared Aug 18, 1997
TULIP
K970129 · ELW
Richard Ting
Dental · 215d
Cleared Aug 18, 1997
DINAMAP COMPACT MONITOR
K970182 · MHX
Johnson & Johnson Medical, Inc.
Cardiovascular · 213d
Cleared Aug 18, 1997
GUIDELINE SYSTEM
K970943 · GZL
Axon Instruments, Inc.
Neurology · 157d
Cleared Aug 18, 1997
BESECURE EXTERNAL URINARY COLLECTION SYSTEM
K971271 · KNX
Urology Research Intl., Inc.
Gastroenterology & Urology · 136d
Cleared Aug 18, 1997
ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER
K971500 · FPA
Biological & Environmental Control...
General Hospital · 116d
Cleared Aug 18, 1997
POTTY PAL AND FOREVER-DRY
K971855 · KPN
Digital Applications, Inc.
Gastroenterology & Urology · 90d
Cleared Aug 18, 1997
EARCHECK
K971859 · ETY
Mdi Instruments, Inc.
Ear, Nose, Throat · 90d
Cleared Aug 18, 1997
MEDISYSTEMS DIALYSIS PRIMING SETS
K971860 · KOC
Medisystems Corp.
Gastroenterology & Urology · 90d
Cleared Aug 18, 1997
SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)
K971874 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 90d
Cleared Aug 18, 1997
BICON DENTAL IMPLANTS II PART ABUTMENT SYSTEM
K972029 · DZE
Bicon, Inc.
Dental · 77d
Cleared Aug 18, 1997
LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES
K972322 · JEY
Walter Lorenz Surgical, Inc.
Dental · 59d
Cleared Aug 18, 1997
V-DELTA 450
K972683 · EJS
Metalor Dental USA Corp.
Dental · 32d
Cleared Aug 15, 1997
MEDISYSTEMS PERITONEAL DIALYSIS SETS
K963668 · KDJ
Medisystems Corp.
Gastroenterology & Urology · 336d
Cleared Aug 15, 1997
VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) &...
K964594 · KNF
Circon Corp.
Obstetrics & Gynecology · 273d