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
86017–86040 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 11, 1999
SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S
K991215 · EFQ
Symtex Healthcare Corp.
General & Plastic Surgery · 63d
Cleared Jun 11, 1999
SYNTHES LOCKING CALCANEAL PLATES
K991407 · LXT
Synthes (Usa)
Orthopedic · 50d
Cleared Jun 11, 1999
CARDIOQUANT CARDIAC ASSESSMENT CONTROLS
K991447 · JJY
Spectral Diagnostics, Inc.
Chemistry · 46d
Cleared Jun 11, 1999
ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEET
K991630 · MDA
Advanced Medical Solutions Group Plc
General & Plastic Surgery · 31d
Cleared Jun 11, 1999
LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR...
K991686 · LYY
Arista Latindo Industrial Ltd. P.T
General Hospital · 25d
Cleared Jun 11, 1999
AT HOME DRUG TEST, MODEL 9171
K991824 · MVO
Phamatech
Toxicology · 15d
Cleared Jun 11, 1999
BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1
K991831 · DPS
Boston Medical Technologies, Inc.
Cardiovascular · 14d
Cleared Jun 11, 1999
SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING
K991842 · IYO
Ge Vingmed Ultrasound
Radiology · 14d
Cleared Jun 10, 1999
11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT...
K980438 · MPB
Medical Components, Inc.
Gastroenterology & Urology · 491d
Cleared Jun 10, 1999
STERI-PAK LF BOWIE-DICK TEST PACK
K990246 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 135d
Cleared Jun 10, 1999
AMORPHOUS DIAMOND COATED DRILL
K990846 · DZI
Nobel Biocare Uas, Inc.
Dental · 87d
Cleared Jun 10, 1999
PILLOWPOSITIVE CERVICAL PILLOW
K990871 · MYB
Lifesleep Systems, Inc.
Ear, Nose, Throat · 86d
Cleared Jun 10, 1999
DRG TITANIUM BONE PLATE
K990920 · JEY
Doctor'S Research Group, Inc.
Dental · 84d
Cleared Jun 10, 1999
AMERICAN DENTAL PRODUCTS ETCH-DETECT
K991099 · EBC
American Dental Products, Inc.
Dental · 70d
Cleared Jun 10, 1999
`INEAR WRIST COIL, MODEL 440GE-09
K991113 · MOS
Medical Advances, Inc.
Radiology · 70d
Cleared Jun 10, 1999
VARIANT II B-THALASSEMIA
K991127 · JPD
Bio-Rad
Hematology · 69d
Cleared Jun 10, 1999
K-ASSAY MICROALBUMIN CALIBRATOR SET
K991166 · JIX
Kamiya Biomedical Co.
Chemistry · 64d
Cleared Jun 10, 1999
BROWNE MVI ETHYLENE OXIDE INDICATOR
K991418 · JOJ
Albert Browne , Ltd.
General Hospital · 48d
Cleared Jun 10, 1999
K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET
K991467 · DHR
Kamiya Biomedical Co.
Immunology · 44d
Cleared Jun 09, 1999
BIOTEST ANTI-EBV RECOMBINANT
K983839 · LSE
Biotest Diagnostics Corp.
Microbiology · 222d
Cleared Jun 09, 1999
BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG
K983841 · LSE
Biotest Diagnostics Corp.
Microbiology · 222d
Cleared Jun 09, 1999
BIOTEST ANTI-EBV RECOMBINANT, EA IGM
K983842 · LSE
Biotest Diagnostics Corp.
Microbiology · 222d
Cleared Jun 09, 1999
FUJI CATHETER, MODEL CTH001
K983867 · KNW
Windy Hill Technology, Inc.
Gastroenterology & Urology · 219d
Cleared Jun 09, 1999
INTERSOURCE 125, MODEL 1251L
K984235 · KXK
International Brachytherapy, Inc.
Radiology · 196d