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
110161–110184 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 1994
BATTERY PACK #1012NC
K931266 · LDD
Portable Power Systems, Inc.
Cardiovascular · 332d
Cleared Feb 03, 1994
FASCIAL CLOSURE DEVICE
K931522 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 314d
Cleared Feb 03, 1994
V.A.D. ACCESS KIT
K932010 · LJT
Clinipad Corp.
General Hospital · 286d
Cleared Feb 03, 1994
TRI-MED INFLATABLE ESOPHAGEAL DILATOR
K932015 · KNQ
Tri-Med Specialties, Inc.
Gastroenterology & Urology · 286d
Cleared Feb 03, 1994
ARTHROBOT BI-FOLD DRAPE
K932253 · KKX
Andronic Devices, Ltd.
General Hospital · 269d
Cleared Feb 03, 1994
CONBIO CUB-D10 COPPER LASER SYSTEM
K932723 · GEX
Buckman Co., Inc.
General & Plastic Surgery · 244d
Cleared Feb 03, 1994
CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN CORE
K932828 · EBF
Alpha-Dent
Dental · 239d
Cleared Feb 03, 1994
MEDTRONIC MODEL 3625 SCREENER SYSTEM
K932948 · GZB
Medtronic Vascular
Neurology · 231d
Cleared Feb 03, 1994
LAPAROSCOPIC RETRACTOR
K933075 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 225d
Cleared Feb 03, 1994
MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR
K933121 · JTY
Bioclinical Systems, Inc.
Microbiology · 223d
Cleared Feb 03, 1994
IMMUNOCARD ROTAVIRUS
K933587 · LIQ
Meridian Diagnostics, Inc.
Microbiology · 192d
Cleared Feb 03, 1994
VIDEO EEG OPTION MODIFICATION
K933951 · GWQ
Esaote Biomedica Spa
Neurology · 175d
Cleared Feb 03, 1994
TOPOGRAPHIC BRAIN MAPPING OPTION
K934050 · OLT
Biosound, Inc.
Neurology · 168d
Cleared Feb 03, 1994
AUTO SUTURE SHARPS CONTAINER
K934088 · FMI
United States Surgical, A Division of...
General Hospital · 163d
Cleared Feb 03, 1994
BIO QUANTUM TECHNOLOGIES, INC. HAND-HELD CO2 LASER SYSTEM MODEL HH-550S
K934089 · GEX
Bio Quantum Technologies, Inc.
General & Plastic Surgery · 163d
Cleared Feb 03, 1994
ZARA ZONE IV MALAR IMPLANT MODIFICATION
K934233 · LZK
Byron Medical
General & Plastic Surgery · 157d
Cleared Feb 03, 1994
UROTEK LASER CATHETER
K934389 · GEX
Energy Life Systems Corp.
General & Plastic Surgery · 147d
Cleared Feb 03, 1994
TRANSWARMER
K934631 · IMD
Prism Technologies, Inc.
Physical Medicine · 132d
Cleared Feb 03, 1994
HASKON MEDICAL GRADE SHEETING
K934829 · MDA
Haskon Intl., Inc.
General & Plastic Surgery · 118d
Cleared Feb 03, 1994
DENTAL DRILL
K934981 · DZP
Eare Consulting Service
Dental · 107d
Cleared Feb 03, 1994
DENTAURUM EXPANSION SCREWS
K935154 · DYJ
Dentauraum, Inc.
Dental · 98d
Cleared Feb 03, 1994
DENTAURUM BAND SEATER AND BAND SEATING INSTRUMENTS
K935156 · ECR
Dentauraum, Inc.
Dental · 98d
Cleared Feb 03, 1994
JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED
K935440 · JES
Johnson & Johnson Consumer Products,...
Dental · 83d
Cleared Feb 03, 1994
WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER
K935505 · FMI
Kawasumi Laboratories Co., Ltd.
General Hospital · 79d