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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
165625–165648 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 1980
BENTLEY THEROMODILUTION CATHETER #BTD-7F
K802133 · KRB
Bentley Laboratories, Inc.
Cardiovascular · 22d
Cleared Sep 26, 1980
2M8101 HEATED LIQUID LEVEL CONTROLLER
K802144 · BTT
Travenol Laboratories, S.A.
Anesthesiology · 21d
Cleared Sep 26, 1980
2C 7140 HEATED HUMIDIFER CANNISTER
K802145 · BTT
Travenol Laboratories, S.A.
Anesthesiology · 21d
Cleared Sep 26, 1980
BOUNDARY SINGLE-USE DRAPE
K802148 · KKX
Procter & Gamble Mfg. Co.
General Hospital · 18d
Cleared Sep 26, 1980
SHERWOOD VENTILATORY MUSCLE TRAINER
K802165 · BYW
Sherwood Medical Co.
Anesthesiology · 18d
Cleared Sep 26, 1980
URIHESIVE SYSTEM
K802172 · KNX
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 17d
Cleared Sep 26, 1980
URIHESIVE STRIPS
K802173 · KNX
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 17d
Cleared Sep 26, 1980
ARGYLE SUCTION CANISTER W/DISP. LINER
K802174 · KDQ
Sherwood Medical Co.
General Hospital · 17d
Cleared Sep 26, 1980
HS10 PORTABLE OPERATING ROOM MONITOR
K802184 · DRT
Medtel Pty. , Ltd.
Cardiovascular · 16d
Cleared Sep 26, 1980
DISPOSABLE NURSES CAP
K802186 · FYF
Anago, Inc.
General & Plastic Surgery · 16d
Cleared Sep 26, 1980
DENTLOID
K802189 · ELW
U.S. Shizai Corp.
Dental · 16d
Cleared Sep 26, 1980
BOUNDARY SINGLE-USE DRAPES
K802192 · KKX
Procter & Gamble Mfg. Co.
General Hospital · 16d
Cleared Sep 26, 1980
BIOMETRIC SYSTOLIC TIME INTERVAL SYSTEM
K802198 · DXG
Biometric Analysis Group, Inc.
Cardiovascular · 16d
Cleared Sep 26, 1980
RION DIAGNOSTIC AUDIOMETER
K802207 · EWO
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 15d
Cleared Sep 26, 1980
CONICAL TIPPED CENTRIFUGE TUBE 15M
K802210 · JQC
Scientific Specialties, Inc.
Chemistry · 14d
Cleared Sep 26, 1980
TENDER-SORB DRAIN SPONGES
K802225 · NAB
Kendall Research Center
General & Plastic Surgery · 14d
Cleared Sep 26, 1980
SECHRIST SERIES 3500 AIR-OXYGEN MIXER
K802226 · BZR
Sechrist Industries, Inc.
Anesthesiology · 14d
Cleared Sep 26, 1980
ANASTIM II TRANSCUTANEOUS ELECTRICAL
K802227 · GZJ
Biostim, Inc.
Neurology · 14d
Cleared Sep 26, 1980
MICRO-BOND HI-LIFE PROCELAIN & VIVERE
K802235 · EIH
Howmedica Corp.
Dental · 11d
Cleared Sep 26, 1980
3M HI-STRENGTH MED. TAPE #1534
K802242 · KGX
3M Company
General & Plastic Surgery · 10d
Cleared Sep 26, 1980
BOUNDARY SINGLE-USE DRAPES
K802247 · KKX
Procter & Gamble Mfg. Co.
General Hospital · 10d
Cleared Sep 26, 1980
DISARP ORIGINAL
K802248 · GAO
Unoplast A/S
General & Plastic Surgery · 10d
Cleared Sep 26, 1980
AIR COMPRESSOR ADAPTOR KIT
K802253 · BTI
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 10d
Cleared Sep 26, 1980
AMES TDA PHENOBARBITAL TEST
K802255 · LET
Miles Laboratories, Inc.
Toxicology · 10d